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Sr Process Engineer
6743 Southpoint Drive North JAX, FL 32216 US
Job Description
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.
- Lead process development, design transfer, and validation activities for neuromodulation devices within the local quality management system to meet the design requirements and manufacturability standards
- Participate in design and development activities, such as tolerance stack analysis, failure analysis, new risk (FMEAs etc.)
- Research and implement technology solutions and methodologies like Design, Reliability & Manufacturability (DRM)
- Lead initiatives to innovate and develop best-in-class process technologies at local manufacturing site
- Support process characterization and validation activities to ensure cost-effective manufacturing cycles, including IQ/OQ/PQ, control plans, MSA (inspection methods), AQL quantity, process flow, and manufacturing protocols
- Ensure suppliers deliver quality parts, materials, and services according to company standards
- Qualify suppliers through rigorous assessment and evaluation of procedures in compliance with enterprise processes
- Monitor supplier performance throughout the manufacturing cycle
- Evaluate and improve suppliers' internal functions and quality management systems through close partnership for shared quality standards
- Work collaboratively with suppliers to resolve quality issues and implement corrective actions
- Provide technical guidance and ensure quality compliance for Supplier Quality engagement throughout the New Product Development (NPD) lifecycle, including pre-market activities.
- Work with NPI teams to ensure seamless integration of new processes within respective quality management systems
- Facilitate communication between design engineering, advanced manufacturing engineering, quality, and supply chain teams to optimize project outcomes
- Support design and manufacturing teams to enhance device functionality and manufacturability
- Engage with regulatory and compliance teams to ensure adherence to industry standards and regulations
- Identify and carry out practical actions to solve technical problems using your new and existing skills in project management, six sigma tools, process characterization and technology development
- Collaborate, document, and present all learnings to project and functional teams
Must Have
- Ability to clearly document work, articulate and present ideas and tests results to a variety of audiences.
- Ability to work as a dynamic team player who can work effectively and proactively on cross-functional teams and on various R&D projects with strong attention to detail
- • Experience in Design for Manufacturability assessment, including emphasis on reduction for complaint handling and released product monitoring
- Experience in Design transfer/Process Validation
- Experience working with contract manufacturers
- Knowledge of statistical methods and design of experiments (DoE)
- Medical device industry experience
- Self-driven engineer who can provide leadership to process development activities
- Strong knowledge and hands on experience in process characterization/development
Nice To Have
- Experience in developing products from concept phase to production release
- DRM certification
- Strong experience with development of new processes at suppliers and/or within internal manufacturing, implementing automation, and developing new fixturing
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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