Manufacturing Process Development Engineer
hace 4 semanas
The Manufacturing Process Development Engineer plays a key role in leading initiatives to mature medical device products from prototype to market through scaling of manufacturing processes and influencing device design to ensure Design for Manufacturability (DFM).
This role collaborates on a global cross-functional level with project stakeholders to define a competitive manufacturing strategy.
Responsibilities- Drive the generation, implementation, qualification, and optimization of fabrication processes for the fabrication of complex polymer consumables from prototype through high-volume manufacturing with expertise and confidence of DFM.
- 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 the agreed-upon timelines and budget.
- Ensure the technological and manufacturing strategy alignment between R&D, PD, and Operations.
- Collaborate with Manufacturing site(s) 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.
- Champion company vision and culture.
- 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 6sigma) such as DoE, FMEA, QFD, etc.
- Experience on scaling up fabrication processes from R&D to manufacturing.
- 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.
- Strong team player.
- Strong understanding of manufacturing transfer and process validation & scale-up.
- Excellent experimental design, data analysis, problem-solving, and decision-making skills.
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Gasteiz / Vitoria, Álava, España Te Connectivity Corporation A tiempo completoJob OverviewThe Process Development and Manufacturing Engineer plays a key role in driving the development and implementation of manufacturing processes for medical device products. This involves scaling up fabrication processes from prototype to high-volume manufacturing, ensuring Design for Manufacturability (DFM) and collaborating with global...
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Gasteiz / Vitoria, Álava, España Te Connectivity Corporation A tiempo completoJob OverviewThe Manufacturing Process Development Engineer plays a key role in leading initiatives to mature medical device products from prototype to market through scaling of manufacturing processes and influencing device design to ensure Design for Manufacturability (DFM).ResponsibilitiesDrive the generation, implementation, qualification, and...
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Gasteiz / Vitoria, Álava, España Te Connectivity Corporation A tiempo completoJob OverviewThe Manufacturing Process Development Engineer plays a key role in leading initiatives to mature medical device products from prototype to market through scaling of manufacturing processes and influencing device design to ensure Design for Manufacturability (DFM).This role collaborates on a global cross-functional level with project stakeholders...
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Gasteiz / Vitoria, Álava, España Te Connectivity Corporation A tiempo completoJob OverviewThe Manufacturing Process Development Engineer is responsible for leading initiatives to mature medical device products from prototype to market through scaling of manufacturing processes and influencing device design to ensure Design for Manufacturability (DFM).This role collaborates on a global cross-functional level with project stakeholders...
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