Process Development and Manufacturing Engineer
hace 17 horas
The Process Development and Manufacturing Engineer is a crucial role in our organization, responsible for 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 project stakeholders on a global cross-functional level to define a competitive manufacturing strategy.
Responsibilities- Drive the generation, implementation, qualification, and optimization of fabrication processes for complex polymer consumables from prototype through high volume manufacturing, ensuring DFM expertise and confidence.
- 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 address 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.
- Strong cross-functional global collaboration between PMO, NPD, CR, Quality, BD, and OPS.
- 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).
- Experience working within an ISO 13485 regulated cleanroom environment (preferred).
- Advanced knowledge of general engineering tools such as DoE, FMEA, QFD, etc.
- Experience scaling up fabrication processes from R&D to manufacturing.
- Knowledge of machining processes, metrology, injection molding, and other relevant techniques.
$120,000 - $150,000 per annum, depending on location and experience.
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