Project Engineer
On-site · Rochester, New Hampshire, United States
Job Summary
Lead end-to-end product development for medical device programs, guiding projects from concept through production launch. Design products and tooling hands-on using SolidWorks CAD, 3D printing, machining, and precision hand tools. Act as primary liaison between internal teams and customers to align on strategy, deliverables, and timelines. Coordinate cross-functional activities across R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain. Oversee production-line launches with procedure development, line clearance, and operator training. Ensure quality/compliance with FDA QSR and ISO 13485; drive IQ/OQ/PQ/PPQ validations and process characterization. Drive continuous improvement in project execution and documentation; communicate status and risks to stakeholders including executives. Mentor junior engineers and strengthen project-management practices. Optimize supplier relationships and identify cost-saving opportunities via process improvements and lean manufacturing principles. Ensure robust documentation and adherence to regulatory requirements.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related engineering discipline
- 7+ years of proven experience in regulated medical device manufacturing or product development
- Advanced proficiency in SolidWorks and cutting-edge design technology solutions
- In-depth knowledge of FDA regulations, ISO 13485, and GMP requirements
- Exceptional documentation, organizational, and communication abilities
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