Senior Mechanical Engineer - Medical Devices

Sunrise Labs Inc • Bedford, NH

just now

About The Position

Responsibilities Lead mechanical design and development of medical device components, mechanisms, and assemblies. Own product development from concept through commercialization, including requirements, design, prototyping, verification, and manufacturing transfer. Design robust, manufacturable solutions using appropriate materials, processes, tolerances, and cost considerations. Conduct risk management activities, including design reviews and FMEA, to ensure compliance with applicable regulations and standards. Create and maintain engineering documentation, including CAD models, drawings, and Design History Files (DHFs). Collaborate with electrical, software, quality, manufacturing, and regulatory teams to deliver integrated products. Mentor and provide technical guidance to junior engineers. Stay current on medical device technologies, regulations, and industry best practices.

Requirements

• B.S. or M.S. in Mechanical Engineering or a related field.
• 7–10 years of product development experience, including at least 5 years in medical devices or other regulated industries.
• Demonstrated experience bringing products from concept to market.
• Proficiency in 3D CAD (e.g., SolidWorks) and PDM systems.
• Strong knowledge of DFM/DFA, GD&T, and mechanical systemdesign.
• Experience with mechanisms and mechanical analysis.
• Familiarity with verification testing, reliability engineering, and human factors considerations.
• Excellent problem-solving, communication, and technical leadership skills.
• Ability to work independently and lead cross-functional design efforts.

Nice To Haves

• Class II or Class III medical devices.
• Fluidics, micro-mechanisms, or disposable device design.
• Hands-on prototyping and test fixture development.
• Exposure to project management tools and agile development methodologies.

Responsibilities

• Lead mechanical design and development of medical device components, mechanisms, and assemblies.
• Own product development from concept through commercialization, including requirements, design, prototyping, verification, and manufacturing transfer.
• Design robust, manufacturable solutions using appropriate materials, processes, tolerances, and cost considerations.
• Conduct risk management activities, including design reviews and FMEA, to ensure compliance with applicable regulations and standards.
• Create and maintain engineering documentation, including CAD models, drawings, and Design History Files (DHFs).
• Collaborate with electrical, software, quality, manufacturing, and regulatory teams to deliver integrated products.
• Mentor and provide technical guidance to junior engineers.
• Stay current on medical device technologies, regulations, and industry best practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees