Manufacturing Engineer - Medical Device

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Location: 4B Gill St Woburn MA 01801
Reports To: Senior Manufacturing & Supply Chain Manager
Employment Type: Full-Time, In-Office
Compensation: $120,000-$140,000

Company Description
Stem Wave is a fast-growing medical device company based in Massachusetts, pioneering orthopedic shockwave technology in the U.S. Our technology is helping change the lives of practitioners and patients by advancing healing and expanding access to effective, non-invasive pain management solutions. Recognized among the fastest-growing privately held companies in 2023 and 2024, we are continuing to expand our team and capabilities to support rapid growth.

We operate at the crossroads of medical device and technology, combining the rigor of a regulated healthcare environment with the speed, ownership, and innovation of a scaling tech company. People are at the center of our growth, and we are building a team of motivated, collaborative individuals who take pride in meaningful work and tangible results.

We hold high standards and believe great performance thrives in an environment that is collaborative, energized, and genuinely enjoyable to be part of. This is a high‑ownership culture where strong ideas are welcomed, teamwork matters, and each new hire plays a meaningful role in shaping the organization we are becoming.

Position Summary
Stem Wave is seeking a Manufacturing Operations Engineer to support production readiness, process optimization, and operational scaling of our medical technology products.

This is a hands‑on, high‑impact role for someone who thrives on solving line‑side issues, improving yield and throughput, and building manufacturing processes in a fast‑paced, evolving environment. You will partner closely with Quality, R&D, and Supply Chain and become a go‑to engineering resource on the manufacturing floor.

• Own day‑to‑day manufacturing support: troubleshoot build issues, investigate defects and nonconformances, and partner with design owners on corrective actions
• Build and scale manufacturing processes: support assembly tooling and equipment selection, define cell layouts, and align process steps with MRP routings
• Improve manufacturing performance: optimize workflows, reduce cycle time, increase throughput, and implement Lean/5S practices
• Assist in Systemic SKU creation and BOM development and control
• Develop and maintain production documentation, including work instructions, visual aids, test methods, travelers, and tooling usage guidelines
• Support equipment and process validations (IQ/OQ/PQ) in alignment with Quality Engineering and regulatory expectations (ISO 13485, FDA 21 CFR 820)
• Drive root cause analysis for line issues using structured problem‑solving methods
• Collaborate on design transfer to ensure BOMs, drawings, specifications, and risk controls translate into manufacturable processes
• Support supplier interactions related to component quality, incoming inspections, and change notifications
• Lead or contribute to yield improvement initiatives using statistical tools (SPC, capability studies, MSA/GR&R, sampling plans)
• Partner with R&D and Test Engineering to ensure production test fixture readiness, calibration, and troubleshooting support
• Monitor production KPIs (scrap, rework, FPY, cycle time) and identify continuous improvement opportunities
• Ensure compliance with all manufacturing, quality, and EHS procedures

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Electrical, or related Engineering discipline
• 3–7+ years of experience in manufacturing or operations engineering within medical device or other regulated hardware environments
• Strong hands‑on experience supporting manufacturing lines and troubleshooting production issues
• Experience with process validations (IQ/OQ/PQ) and documentation within FDA/ISO‑regulated QMS environments
• Proficiency with data analysis tools (Excel, Minitab, or similar)
• Ability to interpret engineering drawings, BOM structures, and tolerance stacks
• Strong documentation skills and familiarity with eQMS or PLM systems
• Excellent communication skills and ability to collaborate cross‑functionally
• Experience…