Senior Process Development Engineer
On-site · Philadelphia, Pennsylvania, United States
Job Summary
Senior Process Development Engineer responsible for developing, implementing and validating manufacturing processes for implantable electronic medical devices; provide technical leadership and mentorship to the engineering team; collaborate with cross-functional teams (Supply Chain, Quality, R&D) on product requirements; manage equipment specification, installation, and validation; handle manufacturing fixture/tooling design and procurement; oversee manual/semiautomatic assembly, laser welding, resistance welding, soldering, surface treatment, molding; perform DOE and range finding, cross sections analysis, process optimization, and risk analyses (PFMEA); maintain thorough documentation and establish workflows to meet quality policies; track KPIs for the team’s performance; utilize CAD/3D modeling, statistical tools and MS Office; ensure compliance with FDA/ISO standards throughout the product lifecycle; strong leadership and communication to guide technicians and engineers across the organization.
Required Qualifications
- Bachelor's degree in engineering (mechanical preferred)
- Minimum of 5 years of experience in developing manufacturing processes in the medical device industry
- Experience with implantable pulse generator assembly preferred
- Strong knowledge of FDA regulations, ISO standards, and other medical device regulations
- Strong problem-solving skills and attention to detail
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced, collaborative environment
- Proficiency with statistical tools, CAD, 3D modeling, Laser/RSW is preferred
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