Senior Production Engineer

About the role

The Senior Production Engineer will design, develop and implement manufacturing processes for medical devices, ensuring efficiency, cost‑effectiveness, safety and regulatory compliance. You will work closely with cross‑functional teams to drive continuous improvement and support production goals.

Key responsibilities

• Monitor and analyze KPIs such as yield, scrap, downtime and cycle time, taking corrective actions as needed.
• Develop and implement process improvements using lean manufacturing principles.
• Troubleshoot technical issues with machinery, equipment or software using root‑cause analysis.
• Coordinate multiple project activities concurrently in a start‑up environment.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, GMP and OSHA regulations.

Required profile

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering or equivalent experience.
• 5‑8 years of experience in a medical‑device or consumer‑electronics environment.
• Experience working in FDA/GMP/ISO regulated settings.
• Ability to work independently and collaborate across functions.

Required skills

• Proficiency with Microsoft Office and online applications.
• Hands‑on ability with basic tools (drills, soldering irons, micrometers, calipers).
• Reading and interpreting mechanical drawings and electrical schematics.
• Knowledge of Quality System Regulations (QSRs/GMPs) and lean manufacturing tools.

What we offer

• Salary range $95,000 – $130,000 per year.
• Comprehensive medical and dental coverage.
• FSA and HSA options with company contributions.
• 401(k) plan with employer match.
• Generous vacation accrual and paid holidays.