Manufacturing Engineer - Medical Devices, Fixture Development

Well-funded 80-Person commercial-stage medical device company with multiple products on the market.

Products:
Min-invasive electromechanical hand-held instruments & disposable devices.

Design of new test & production fixtures, and supplier industrialization to support the development and scale-up of medical device products. This role is responsible for developing and executing validation protocols, and implementing robust manufacturing processes at external suppliers.

The ideal candidate combines strong mechanical design skills with hands-on manufacturing experience and a solid understanding of regulated environments.

• Design, develop, and release custom fixtures and tooling to support assembly, inspection, and testing of medical devices
• Create detailed CAD models and drawings for fabrication and supplier use
• Collaborate with suppliers to ensure manufacturability, durability, and cost-effectiveness of tooling
• Work directly with contract manufacturers and suppliers to deploy tooling into production environments
• Provide on-site or remote support for tooling bring-up, debugging, and process stabilization
• Drive DFM/DFA improvements with suppliers and internal design teams
• Develop and execute IQ/OQ/PQ validation protocols for tooling and manufacturing processes
• Author validation documentation in compliance with U.S. Food and Drug Administration (FDA) and ISO standards (e.g., ISO 13485)
• Analyze data from validation runs and implement process improvements to meet quality and yield targets
• Design and implement test methods and inspection fixtures for product verification
• Perform root cause analysis and drive corrective actions for tooling/process-related issues
• Partner with R&D, Quality, and Supplier Quality teams to ensure design transfer readiness
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOMs, DMRs, Routers, Manufacturing Instructions, FMEAs, etc.);
  Generates documentation changes/justification through ECO process.
• Plans, organizes, and conducts all aspects of technical reviews.
• Must be able to travel 1-2 time(s) per quarter

• Bachelor’s degree in Mechanical Engineering or related field
• 3–7+ years of experience in a Medical Device Manufacturing Engineering environment
• Experience with medical device instruments and/or disposable products
• Experience designing assembly fixtures, test fixtures, or automation tooling
• Experience working with contract manufacturers or suppliers

• Strong verbal and written communication skills.
• Hands-on experience with process validation (IQ/OQ/PQ)
• Familiarity with ISO 13485 and 21 CFR Part 820
• Knowledge of statistical tools (e.g., DOE, process capability analysis)
• Experience with machining, injection molding, or automated assembly systems
• Experience with process validation and documentation
• Ability problem-solve in production environments
• Ability to work in a fast-paced environment where priorities are dynamic; must have well developed task/activity prioritization optimization skills
• History of success in being able to conceptualize, design, assemble and debug tooling and fixtures; optimize existing and new manufacturing processes.
• Strong sense of urgency, follow-through, and personal accountability.
• Ability to lift at least 40 lbs. and transport equipment as needed.
• Ability to travel to supplier sites (10–25%)

This position will report to a VP Operations & Engineering, and be part of a small team of manufacturing engineers (5 people).

Must be a US Citizen or have currently US Work Authorization (Green Card).

No H1B sponsorship or transfers or C2C candidates will be accepted