https://CAREERS.PLANET-PHARMA.COM/ en-us The main function of the Clinical Research Specialist is to support clinical study start?up, execution, and closeout with a strong emphasis on maintaining an inspection?ready Trial Master File (TMF).
Responsibilities include organizing, reviewing, and quality?checking essential documents in the eTMF and CTMS to ensure compliance with GCP, regulatory requirements, and internal SOPs.
The Specialist identifies and investigates documentation discrepancies, supports data review and query resolution with cross?functional teams, and contributes to process improvements that enhance efficiency and documentation quality across clinical studies.

Key Responsibilities:

Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit, and other associated supporting tasks), as well as study execution and closure activities
Organize and manage documents in the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) to ensure compliance with internal procedures.
Review clinical data for completeness across multiple research trials and conduct thorough documentation reviews for internal and external audits (e.g., FDA, TUV, PMDA) to ensure all essential Trial Master File (TMF) documents adhere to Good Documentation Practices, Edwards' internal SOPs, and relevant US and OUS regulations.

Review, identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study conduct and closeout

Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

Supports assessments of current processes, identifies opportunities and assists with improving process efficiency within and across related functional areas

Education and Experience Requirements:

Bachelor's Degree or equivalent in related field

1-2 year of clinical research experience required
 

Additional Skills (Preferred):

• Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Good understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Strict attention to detail
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group

Pay $33-41/hr based on experience]]> Tue, 10 Mar 2026 00:00:00 EDT 1 *Depending on experience

Job Description
Our Senior Representatives will deliver excellent customer service to customers with elevated expectations! You will support our customers by instilling trust, driving results, and staying patient focused! The ability to change hats and work as a team and independently is essential to success. You are the first point of contact and will own the customer experience from start to finish. Each interaction will require the ability to follow our processes with speed and accuracy. A performance-based organization that rewards diligent workers.

This position includes but is not limited to the following:

Responsibilities:
• Use of case management system to manage customer contacts and order detail with razor sharp accuracy
• Proactively track, resolve, and escalate order or cases in alignment with service excellence standards
• Place and monitor orders via phone, fax, and email for hospital and sales rep customers
• Orders translate to new orders, Returns, Billing, Inventory adjustments, reconciliations, and FCAs/Recalls.
• Own it! Proactively communicate backorders, order status, product availability, and missed deliverables
• Resolve complex issues via root cause analysis investigation, proposal of resolution, and resolution implementation with limited intervention
• Prioritize high work volumes from phones, email, case management, and faxes
• Become a SME (Subject Matter Experts) who can coach and train others
• Systematically process and transact consignment conversions & reconciliations
• Perform basic data analysis and generate reports for Sales, Customers, and Consignment Team
• Process customer returns and coordinate with Inventory Teams to ensure product is received
• Complete customer credits following documentation guidelines under SOX key controls
• Communicate regularly with Supply Chain Planning for inventory availability
• Perform at a level to meet and sustain department metrics and expectations


Basic Requirements:
• H.S. Diploma is required
• Minimum of 4 years Customer Service Experience
• Excellent written and verbal communication, interpersonal and relationship building skills with focus on negotiating and persuasion
• Ability to work in a demanding environment
• Excellent Customer Service skills with ability to negotiate and resolve demanding situations
• Ability to build and maintain strong relationships across the organization to influence and achieve objectives
• Strong Time Management Skills with ability to prioritize competing objectives
• Must be able to work in a team environment with minimum supervision, this includes inter-departmental and cross-departmental business partners
• Demonstrates problem-solving and critical thinking skills
• Proficient in MS Office Suite
• Experience within an ERP software
• Ability to manage confidential information with discretion
• Strict attention to detail

Preferred Qualifications:
? Bachelor’s degree is preferred (BA/BS degree is necessary to promote within)
? Salesforce experience or CRM experience
? Proficient in JDE (ERP Software)]]> Mon, 09 Mar 2026 00:00:00 EDT 1
Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. Travel is required. Excellent verbal, written, interpersonal and presentation skills are required. Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project. Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective.

Pay ranges between 45-54/hr based on experience]]> Mon, 09 Mar 2026 00:00:00 EDT 1 Target PR Range: 36-36/hr
*Depending on experience
Major Responsibilities:
• Perform cGMP cell-based potency assays testing in support of the manufacture of biologics products. Responsible for the timely completion of assigned laboratory testing.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.
• Generate and update SOPs.
• Adhere to and supports all EHS standards, procedures and policies.
• Understand regulations and business processes required to maintain laboratory data integrity.
• Maintain and comply with laboratory documentation and computerized systems data integrity requirements.


Regulated Responsibilities (including cGMP and EHS):
Regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.




Qualifications:
• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
• Proficiency in quality systems, Microsoft Project, and Excel.
• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.
• Experience with aseptic cell culture and cell banking preferred.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Job Overview
• Responds to unsolicited medical requests regarding products from HCPs, members of the public, and internal colleagues. Responses are provided in a timely manner using approved standard documents, up-to-date literature support and other resources
• Uses scientific and MI expertise to drive strategic initiatives and empower key stakeholders, HCPs, patients and other requestors with globally aligned resources that enable timely, informed decisions and improved patient outcomes
• Prepares global resources in collaboration with local affiliate teams (TA specialist team). Prepares local resources (affiliate MI specialist team). Vendors may be used
• Identifies, reports and records adverse events and product complaints in a timely manner in accordance with SOP. May be asked to provide medical review for promotional and/or medical materials

Responsibilities
Routine responsibilities may include the following
• Respond to unsolicited requests for medical and scientific information regarding products and documents in the request handling system (MiQ)
• Researches and collaborates with cross functional colleagues to provide response to complex requests. TA specialist responds to complex requests from affiliate MI and internal colleagues
• Create, update, and participate in review and quality check of MI response documents in accordance with local laws and regulations
• MI specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content
• MI specialist prepares data on file to support response documents and complex requests
• Maintain document repository with regular/routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials
• Understand the needs and preferences of internal and external partners and customers
• Review and provide analysis of MI databases for trends, customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
• May oversee and/or evaluate external consultant writers
• MI specialist provides process and product training to colleagues and vendors as required
• Support departmental strategic initiatives to address major activities within TA (product launches, labelling updates, patient engagement etc.)
• Identify, report and record adverse events and product complaints in a timely manner in accordance with SOP
• Participate in MI activities and projects in line with global and regional strategic MI plans
• Works under supervision of manager or colleague

Knowledge and Skills
• Excellent written, verbal and interpersonal communication skills, and the ability to work well in multidisciplinary teams, across geographies
• Ability to create and provide clear communication of scientific data for different audiences, including members of the public
• Knowledge and understanding of marketed and investigational products
• Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment, with understanding of regional or country regulations related to the provision of MI services
• Ability to provide analysis and evaluate clinical, biomedical and scientific data
• Ability to develop and maintain good working relationships with departmental and cross-functional colleagues
• Understanding of internal and external stakeholder needs and priorities
• Serve as an advocate for MI affiliate or Global MI
• Demonstrates core values and Leadership Commitments
• Has a strong attention to detail, excellent project management and problem-solving skills, and ability to think creatively
• Good organizational and work planning skills and ability to manage multiple projects in a fast-paced environment
• Awareness of digital solutions for communicating with healthcare providers and patients
• Previous experience with problem-solving and project management preferred

Education and Experience
• Pharmacy, Nursing or Medical/ Life Sciences degree/advanced degree or equivalent (PharmD preferred)
• Experience in MI or working in a healthcare environment preferred.
• Experience in the pharmaceutical industry or a MI vendor preferred.
• Experience in Cell Therapy, Hematology or Oncology preferred

Pay ranges between 50-55/hr based on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 1 *Depending on experience

Applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines.

Key Responsibilities:
• Use tools - needles, scissors, forceps, specialized tooling, microscope - to perform assigned steps, in rotation, in the sewing assembly of valves
• Perform verifications, against specifications, of completed steps, and successive checks on steps completed by work team colleagues
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
• Other incidental duties: General work area housekeeping

Preferred Additional Skills:
• Preferred Previous sewing, GMP, clean room, medical device experience
• Basic computer skills required
• Good hand eye coordination, required
• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Must be able to work in a team environment and with minimum supervision by following detailed manufacturing instructions
• Successful completion of ongoing job training of assembly process steps
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education/Experience:
• High school diploma or GED required.
• 0-2 years experience required.]]> Thu, 05 Mar 2026 00:00:00 EST 1
Summary:
The main function of a maintenance technician is to perform work involving the skills of two or more maintenance or craft occupations to keep machines, mechanical equipment, or the structure of an establishment in repair.

Job Responsibilities:
• Repair or replace defective equipment parts, using hand tools and power tools, and reassemble equipment.
• Perform routine preventive maintenance to ensure that machines continue to run smoothly, building systems operate efficiently, or the physical condition of buildings does not deteriorate.
• Inspect drives, motors, and belts, check fluid levels, replace filters, or perform other maintenance actions, following checklists.
• Use tools ranging from common hand and power tools, such as hammers, hoists, saws, drills, and wrenches, to precision measuring instruments and electrical and electronic testing devices.
• Assemble, install or repair wiring, electrical and electronic components, pipe systems and plumbing, machinery, and equipment.
• Inspect, operate, and test machinery and equipment to diagnose machine malfunctions.
• Record type and cost of maintenance or repair work.
• Clean and lubricate shafts, bearings, gears, and other parts of machinery.
• Dismantle devices to access and remove defective parts, using hoists, cranes, hand tools, and power tools.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic knowledge of machines and tools, including their designs, uses, repair, and maintenance.
• Basic knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Basic knowledge of the practical application of engineering science and technology.

Education/Experience:
• High school diploma or GED required.
• 5-7 years experience required.

Comments
Work Days will be Tuesday to Saturday. 0530am to 200pm]]> Thu, 05 Mar 2026 00:00:00 EST 1 Manager, NPD Program Management 

Job Description:

The NPD (New Product Development) Program Manager will be responsible for successfully leading NPD teams through the various stages of product and algorithm development, clinical evaluations, operational readiness, and commercialization for new and improved Hemodynamic Monitoring products and related accessories and disposables. This person will be responsible for initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of program(s), to ensure on-time commercialization of new products and technologies that uphold best in-class quality standards and business objectives.

Key Responsibilities:

•          Manages one or more large scale to enterprise-wide projects within program, assuring strict adherence to Quality Systems and Change Control Process
•          Facilitates the creation and approval of business cases within the program, and coordinates the sharing and prioritization of resources among projects
•          Develops a detailed plan for the program and manages program change accordingly
•          Executes program plans (quality, risk, communication, staffing, etc.) and communicate program status and data to maintain accurate and current program information for the use of stakeholders
•          Leads core team meetings and other necessary meetings to drive best in class program execution; Continually improves quality and effectiveness of how meetings are run, decisions are made, and how work gets done
•          Serves as a project and program management subject matter expert, including guiding and mentoring peers
•          Demonstrates high emotional intelligence; builds trust, rapport and respect with project team members and stakeholders; Engages in honest and transparent conversations
•          Creates a culture where teams can act with a high sense of urgency and accountability to meeting/exceeding individual and project goals
•          Understands complex problems and drives the team to effective resolution
•          Displays perseverance and continues appropriate forward momentum by keeping core team engaged, even when faced with crisis, and/or changes
•          Demonstrates strong ability to influence downward, horizontally, and upward.

Experience:

•           A minimum of 6 years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity -- Required
•          Demonstrated track record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Hardware and Disposable components – Required
•         Proficient understanding of Medical Device Regulations and Product Development Process – Required
•          Demonstrated track record of leading within complex organizations requiring strong influence management skills
•          Proven expertise in usage of MS Office Suite and related project management systems
•          Ability to see the “big picture” and determine course of action from an overall “best for the business” perspective
•         Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions
•          Ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
•          Effective decision-making skills -- ability to negotiate and balance decisions and priorities across needs of several functional departments. Makes timely decisions in the face of risk and uncertainty

Additional Skills:

•          Working knowledge of Agile/Scrum methodology and related project management software: Jira, Microsoft DevOps, etc.
•          Strict attention to detail
•          Ability to lead meetings with external representatives
•          Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education:

•          Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field – Required
•          Master's Degree or equivalent – Preferred
•          PMP Certification - Plus

Pay $60-67/hr based on experience]]> Wed, 04 Mar 2026 00:00:00 EST 1
Summary:
The main function of a maintenance technician is to perform work involving the skills of two or more maintenance or craft occupations to keep machines, mechanical equipment, or the structure of an establishment in repair.

Job Responsibilities:
• Repair or replace defective equipment parts, using hand tools and power tools, and reassemble equipment.
• Perform routine preventive maintenance to ensure that machines continue to run smoothly, building systems operate efficiently, or the physical condition of buildings does not deteriorate.
• Inspect drives, motors, and belts, check fluid levels, replace filters, or perform other maintenance actions, following checklists.
• Use tools ranging from common hand and power tools, such as hammers, hoists, saws, drills, and wrenches, to precision measuring instruments and electrical and electronic testing devices.
• Assemble, install or repair wiring, electrical and electronic components, pipe systems and plumbing, machinery, and equipment.
• Inspect, operate, and test machinery and equipment to diagnose machine malfunctions.
• Record type and cost of maintenance or repair work.
• Clean and lubricate shafts, bearings, gears, and other parts of machinery.
• Dismantle devices to access and remove defective parts, using hoists, cranes, hand tools, and power tools.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic knowledge of machines and tools, including their designs, uses, repair, and maintenance.
• Basic knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Basic knowledge of the practical application of engineering science and technology.

Education/Experience:
• High school diploma or GED required.
• 2-4 years experience required.]]> Tue, 03 Mar 2026 00:00:00 EST 1
Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.

Key Responsibilities:
• Ensure successful product lifecycle management, from early human use through commercial submission
• Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
• Provide scientific rationale for product attributes and pre-clinical test results
• Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel
• Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
• Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.
• Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
• Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
• Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
• Analyze data to support clinical trial safety investigations and new product development
• Other duties as assigned by leadership

Education and Experience:
Bachelor's Degree in biology or lifesciences field, 5 Years years experience Class II and III medical device technologies and/or clinical studies background Required
Bachelor's Degree in engineering Preferred

Additional Skills:
• Proven expertise with computer skills - Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with pre-clinical testing protocols, hospital environments and sterile techniques
• Data analysis skills, with understanding of statistical analysis techniques
• Good communication and organizational skills
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Demonstrated problem-solving and critical thinking skills
• Thorough, conscientious and results oriented working style
• Team oriented
• Ability to work in a dynamic work environment
• Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred]]> Fri, 27 Feb 2026 00:00:00 EST 1 As a project manager you will plan, direct, and coordinate project activities for successful completion of all project deliverables to the business within established schedule, scope, financial and quality objectives. Projects will be for the Technical Service organization including launching service capabilities on new electronic products to our global service centers. The role will be onsite. 

Responsibilities:

• Manage project initiation/planning, execution, controlling, and closing phases.
• Manage large scale to enterprise-wide projects within program.
• Create and manage project schedule and action item trackers.
• Develop a high-level milestone plan for the program and manages program change in accordance with the change management plan to control scope, mitigate risks, quality, schedule, cost, and contracts.
• Establish and maintain program stakeholder relationships, expectations, and communications, both internal and external to the organization.
• Manage and control changes from original scope for every project.
• Serve as conduit between project/team members in all cross-functional groups.
• Perform other duties and responsibilities as assigned.

 

Preferred Qualifications:

• Degree in engineering, science or related is preferred.
• Regulated manufacturing environment is preferred.
• Experience with regulatory agency guidelines for medical device manufacturers is highly preferred.
• Project Management Professional (PMP) Certification is preferred.
• Proven track record in the management of multiple complex, large-scale projects with the ability to prioritize projects.
• Advanced skills in using and creating schedules in Microsoft Project.
• Ability to proactively escalate issues to appropriate levels of management in the organization.
• Must have excellent verbal and written communication skills.
• Ability to influence and build strong relationships is essential.
• Working experience managing resources and influencing others to action who are not direct reports.
• Possess and display sound judgment; initiative; flexibility and detail-orientation.
• Ability to adapt to new technologies and rapidly changing environment.
• Self-motivated and frequently demonstrates initiative by going “above and beyond” performing what is required for the position.
• Knowledge and work experience with Project budgets and financial management is a plus.

Pay $45-47/hr ]]> Thu, 26 Feb 2026 00:00:00 EST 1 *Depending on experience

Summary:
The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints, and evaluate product integrity and standards.

Job Responsibilities:
• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
• Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
• Strong leadership and collaboration with other leaders in project and across the organization
• Mentor engineers in understanding of quality systems and strategies within new product development.
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
• Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
• Train, coach, and guide lower-level employees on more complex procedures
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic leadership and mentoring skills necessary to provide support and constructive performance feedback.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.]]> Wed, 25 Feb 2026 00:00:00 EST 1
Role Description:

The Supplier Quality Engineer II will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Operations, Quality, Sourcing, and RA.

Job Function:

• Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Works with suppliers to ensure quality system and supplied product requirements are understood and successfully met.
• Responsible for helping define supplier qualification requirements for OEM and custom materials and devices.
• Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and Industry best practices.
• Supports completion of Design Development File requirements applicable to supplied components, subassemblies, devices, and services.
• Supports risk management and validation activities with suppliers.
• Develops inspection methods and procedures for receiving inspection and/or supplier final release.
• Executes test method validation activities for receiving inspection and/or supplier final release.
• Knowledge of NCR & CAPA elements is preferred.
• Assesses non-conformances and leads closure of SCARs as needed.

Required Education / Qualifications:

• Bachelors degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions
• Highly regulated industry experience

Preferred Qualifications:

• Engineering degree
• Experience with supplier quality engineering activities, including external supplier vendor audits
• Effective problem-solving techniques and experience with technical tools (i.e. Root Cause Analysis, dFMEA process, Gage R&R, etc.)
• Proficient understanding of Design Controls, test method development & validation, and risk management.
• Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
• Experience with class II and class III medical devices
• Medical device, pharma, biotech or other regulated industry experience
• Demonstrated ability to apply statistical quality engineering tools
• Ability to read and interpret drawings
• Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred.
• Ability to manage multiple and frequently changing projects and priorities.
• Ability to work independently without close supervision
• Effective communication and conflict resolution skills
• Highly developed time management, communication, and documentation skills
• Strong communication and organizational skills to effectively manage and get results with external suppliers
• Six Sigma Black Belt/LEAN Manufacturing experience
• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
• Domestic and international travel up to 25% (post-COVID)]]> Wed, 25 Feb 2026 00:00:00 EST 1
Summary:
The primary responsibility of the Clinical Data analyst is to support CDM study startup activities, including developing database specifications, authoring and executing test scripts, and preparing key CDM deliverables.

Key Responsibilities:
• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
• Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), CRF completion guidelines, training materials and user aids in compliance with regulations.
• Perform Site/User Administration including generating and validating EDC reports and Subject PDFs.
• Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
• Assist in leading project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
Skills:
• Experience with Medidata EDC (Electronic Data Capture) systems required. Experience with InForm EDC system preferred.
• Good computer skills in Microsoft Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills

Education and Experience:
• Bachelor's Degree or equivalent
• 5-7 years of experience required]]> Thu, 19 Feb 2026 00:00:00 EST 1 *Depending on experience

Our Senior Supplier Development Engineer position is a unique career opportunity that could be your next step towards an exciting future.
The Senior Supplier Development Engineer role will reside in the Advanced Technology (AT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews, supply chain readiness review and manage design transfers to manufacturing.

How you'll make an impact:
Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and receiving inspection fixture design for Test method validation.
Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
Develop and manage project milestones in line with development and commercialization needs.
Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
Audit suppliers for their technical capabilities as well as quality criteria.
Perform other duties and responsibilities as assigned.

What you'll need (Required Qualifications):
Bachelor's Degree or equivalent in Engineering or Scientific field with, 4 years experience including either industry or industry/education OR
Master's Degree or equivalent in Engineering or Scientific field with, 3 years experience including either industry or industry/education.
On-site work required.
Up to 20% domestic/international travel required.
What else we look for (Preferred Qualifications):
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
CAD experience using ProE/Solidworks
Strong analytical, problem solving and technical writing skills.
Strong Project management skills.
Ability to work well both independently and as a member of a team.
Effective verbal/written communication and interpersonal skills including conflict and relationship management.]]> Tue, 17 Feb 2026 00:00:00 EST 1
You will work at the interface of biology and technology and will support the effort on assessment and development of custom NGS needs, to assist drug target and biomarker discovery efforts.

Responsibilities
• Extraction and preparation of DNA and RNA from various sources
• Preparation of DNA, RNA, and ATAC-seq libraries from bulk and/or single cells for NGS sequencing
• Perform quality control on samples and libraries.
• Troubleshoot the experimental procedures and protocols for library preparation and sequencing under supervision
• Perform Next Generation Sequencing experiments on Illumina platforms and other platforms
• Perform qPCR for library quality control
• Maintain updated working knowledge of Genomics technologies and develop significant experience in next-generation sequencing applications
• Keep records of experiments in electronic notebook (ELN)
• Deliver scientific findings effectively in group meetings and collaborative forums

Basic Qualifications
Masters Degree
OR
Bachelors Degree and 2+ years of scientific experience
OR
AA Degree and 4+ years of scientific experience
OR
High School Degree and 5+ years of scientific experience

Preferred Qualifications
• Bachelor's degree in Biological Sciences, Molecular Biology, Biochemistry, Bioengineering, Genetics, or related fields
• 2+ years of hands-on experience with Next Generation Sequencing (NGS) platforms, various NGS assays, and their underlying sequencing methodology
• Hands-on experience with DNA and RNA extraction from various sources
• Ability to learn new techniques in a fast-paced environment
• Demonstrated ability to solve scientific and engineering problems
• Excellent organizational skills and efficiency at getting tasks done
• Goal oriented and looking to take on additional responsibilities
• Experience working in a multi-disciplinary environment
• Experience working with LIMS and electronic notebook e.g. Benchling
• Excellent interpersonal, verbal, and written communication skills
• An excellent work ethic, ability to work in a dynamic environment, and ability to adapt to changing priorities

Pay ranges betwen 48-51/hr based on experience ]]> Mon, 09 Feb 2026 00:00:00 EST 1