Process Engineer – Medical Device Manufacturing
Location: Franklin, MA | Full-Time
About the Role
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.
Key Responsibilities
- 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.
Qualifications
- 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.
Why Join Us
- Contribute to the development of life-changing medical technologies.
- Work in a collaborative, innovation-driven environment.
- Competitive compensation, benefits, and career growth opportunities.
Who we are:
KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and operating room integration to benefit patients and healthcare providers alike.
With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create—it’s about the lives we change, together.
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