Manufacturing Process Development Engineer
hace 4 semanas
Job Title: Manufacturing Process Development Engineer
Job Summary:
The Manufacturing Process Development Engineer plays a crucial role in leading initiatives to mature medical device products from prototype to market. This involves scaling manufacturing processes and influencing device design to ensure Design for Manufacturability (DFM). The successful candidate will collaborate with global cross-functional stakeholders to define a competitive manufacturing strategy.
Responsibilities:
- Drive the generation, implementation, qualification, and optimization of fabrication processes for complex polymer consumables from prototype to high-volume manufacturing.
- Generate and own product requirement documents, test plans, V&V reports, PFMEAs, and Engineering Change Orders.
- Utilize statistical process control for product development, validation, and manufacturing optimization.
- Plan and implement measures to fill technical gaps, risks, or failures within the organization.
- Specify and implement new manufacturing equipment.
- Maintain collaborative relationships with clients and ensure expected deliverables are met or exceeded within agreed-upon timelines and budget.
- Ensure technological and manufacturing strategy alignment between R&D, PD, and Operations.
- Collaborate with Manufacturing sites to proactively plan for and support product transfer.
- Leverage lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows.
- Obtain components, supplies, and equipment to support prototype assembly and conduct preliminary OEM vendor assessment and selection.
Requirements:
- Bachelor's Degree in Engineering, Manufacturing, or equivalent.
- 5 or more years of industry experience in process development and manufacturing (Life Science or related industries preferred).
- Worked within an ISO 13485 regulated cleanroom environment (preferred).
- Advanced knowledge of general engineering tools (LEAN or 6-sigma) such as DoE, FMEA, QFD, etc.
- Experience in scaling up fabrication processes from R&D to manufacturing.
Preferred Experience:
- Photolithography for mold generation.
- Electroplating for nickel shim generation.
- DRIE on silicon.
- Wet silicon and glass etching.
- Sputtering.
- Evaporation.
- Soft-lithography.
- Machining processes (CNC milling, micro-milling, drilling, laser welding, grinding...).
- Metrology.
- Injection molding.
Skills:
- Strong team player.
- Strong understanding of manufacturing transfer and process validation & scale-up.
- Excellent experimental design, data analysis, problem-solving, and decision-making skills.
- Autonomy in owning a process and troubleshooting issues.
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