Manufacturing Process Engineer
8 hours ago
Meet Our Team: Senior Manufacturing Engineer
A leading medical device company is seeking a highly skilled Senior Manufacturing Engineer to join their team. As a key member of the manufacturing engineering department, you will play a critical role in leading and executing manufacturing projects to support new product introduction, process development and optimization, and manufacturing scale-up efforts.
Key Responsibilities:
- Develop and implement new manufacturing processes for new and current medical devices, ensuring compliance with regulatory requirements.
- Collaborate with global suppliers to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are being delivered.
- Conduct characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
- Create and maintain manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
- Lead a team of engineers and technicians on business activities for manufacturing, providing guidance and support as needed.
- Drive innovation, design, and development of processes, procedures, tooling, and automation to improve manufacturing efficiency and productivity.
Requirements:
- Bachelor's Degree in Engineering (Mechanical, Electrical, or similar)
- Minimum of 4 years experience as a process/manufacturing engineer in the medical device industry, 6-7 years of experience preferred.
- Proven experience in electromechanical/electronics medical device manufacturing, with knowledge of IEC 60601-x and ISO 13485.
- CNC manufacturing experience and proficiency in FMEA, root cause analysis, and GD&T.
- Excellent technical writing skills, with experience creating technical manufacturing documentation.
- Strong understanding of medical device Quality Management Systems, design controls, and product development processes.
- Proficiency in SolidWorks/CAD software.
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