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Process Engineer II
35 Cherry Hill Drive Danvers, MA 01923 US
Job Description
Top 3 technical skills that are required for the role:
- Validation Experience IQ/OQ/PQ
- Test Method Validation
- Problem Solving/Process Improvements
Education Required: At least a Bachelor's
Years’ Experience Required: 2+
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours/week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? onsite
What is your timeline for scheduling interviews? Jan 6th -
What product line will this person support? Sensight VAVE and Elastane Replacement
Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation development and/or optimization of new manufacturing concepts processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work material selection process and equipment selection tooling fixture and equipment installation and assessment of inputs outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering RampD systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger moderately complex projects amp assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information status needs and issues in order to inform gain input and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree or for degrees earned outside of the United States a degree and minimum of 2 years of relevant experience
Nice To Have
- Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
- Examples of critical thinking and proven project execution
- Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc.
- Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
- Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
- Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
- Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, Is/Is not, etc. Drive solid decision making.
- Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
- Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges
- Application of statistical and analytical methods such as SPC, SQC, and DOE.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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