North Shore, MA
80 to 100 K$/yr
Senior Manufacturing Engineer with strong background in medical device / medical products manufacturing including medical electronics. You will design, develop, improve and validate manufacturing processes, tooling, and fixtures in order to meet daily production schedules, reduce defects and enhance productivity and product quality. Direct hire position located north of Boston.
- Support prototype, V+V, pilot and commercial production of new products, product changes, and enhancements in coordination with the Operations, Product Development and Quality Assurance organizations.
- Use Lean and Six Sigma tools to analyze process trend data or communicate issues based upon a data driven approach.
- Support and enforce Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
- Develop and maintain associated process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
- Identify and execute process validations including generation of plans, protocols and reports.
- Oversee outside supplier activity as appropriate, ensuring all technical issues are resolved in order to meet production demand.
- Qualify and optimize manufacturing processes and tooling via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies and Designs of Experiments.
- Participate in the investigation of failures and formulation and implementation of action plans for all internal corrective actions and audit findings. Address WIP and Incoming MRB in a timely manner.
- Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments
- BS in Electrical Engineering, Manufacturing Engineering or Industrial Engineering required, MBA or MS preferred.
- 8 years Medical device experience including some experience with medical electronics manufacturing
- ISO, GMP and IPC required.
- International travel (10%-25%) required
- Full medical coverage. Up to 10% bonus!