Mechanical Engineer
On-site · Biddeford, Maine, United States
Job Summary
Senior Mechanical Engineer to drive conceptualization and detailed design of complex optomechanical systems for the biomedical market. Responsible for 3D CAD design, advanced engineering analyses (FEA, CFD), GD&T tolerance analysis, customer specifications translation, full prototyping lifecycle, root-cause analysis, V&V test planning, ISO 13485 compliance, design transfer to manufacturing (DFM/DFA), materials/process selection for medical devices, and mentoring of junior engineers. Office location is So Maine with the company’s Biddeford, ME facility; role reports to Engineering/Production Director and emphasizes leadership in a highly regulated environment.
Required Qualifications
- Bachelor’s degree in Mechanical Engineering (or related field)
- experience in mechanical design and development, preferably in optics, photonics, or related industry
- expert-level proficiency in 3D CAD (SolidWorks preferred)
- deep expertise in core mechanical design principles (stress analysis, heat transfer, vibration) and mastery of GD&T (ASME Y14.5)
- strong background in manufacturing processes and simulation tools
- experience with ISO 13485, FDA design control regulations, and ISO 14971 within a QMS
- demonstrated ability to lead major design efforts from concept to product launch
Additional Requirements
- US Citizen or Green Card holders only
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