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We are seeking a Process Engineer III with strong manufacturing experience to support machining operations in the medical device industry. This role involves development and improvement of machining processes, solving complex manufacturing challenges, and driving process improvements to ensure precision, compliance, and efficiency. You will play a key role in equipment selection, capacity planning, and cost analysis while collaborating across engineering, quality, and production teams.
Job Responsibility:
Develop machining processes and operation sheets from engineering data for complex medical devices
Implement new or improved manufacturing methods, tools, and equipment designs to optimize performance
Lead cost reduction initiatives and evaluate outside processes for quality and efficiency
Design and implement assembly tooling, jigs, and fixtures
Manage multiple projects, track progress, and report regularly to management
Partner with Quality to analyze data and drive corrective actions
Create and maintain clear, accurate documentation to support production, compliance, and knowledge transfer
Ensure compliance with FDA, ISO 13485, ISO 9001, and GMP standards
Train personnel and provide daily communication across departments to resolve production issues
Requirements:
Bachelor’s degree in Mechanical or Industrial Engineering
5+ years of experience in machining, CNC equipment, and medical device assembly
Strong knowledge of GD&T, metrology tools (CMM, profilometer, vision systems), and process monitoring
Familiarity with GMP, ISO, Lean manufacturing
Lean Six Sigma certification a plus
Experience with ERP systems (SAP/Oracle) and MS Office tools (Word, Excel, Project, PowerPoint)
Excellent communication skills and ability to manage multiple priorities
Proven ability to generate thorough documentation for processes, tooling, and testing
Nice to have:
Lean Six Sigma certification
What we offer:
Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave
includes maternal/ paternal leave, adoption, and fostering of a child
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)