Senior Mechanical Engineer (Medical Devices)

TL;DR

Senior Mechanical Engineer (Medical Devices): Leading the mechanical design and development of medical device components and assemblies with an accent on the entire product lifecycle from concept to commercialization. Focus on designing robust, manufacturable solutions, conducting risk management (FMEA), and ensuring strict compliance with medical regulations.

Location: Bedford, NH, USA

Company

hirify.global specializes in the development and engineering of innovative medical device technologies.

What you will do

• Lead the mechanical design and development of medical device components, mechanisms, and assemblies.
• Own the entire product development process from concept through commercialization, including prototyping and manufacturing transfer.
• Design robust, manufacturable solutions using optimized materials, processes, and tolerances.
• Conduct risk management activities, including design reviews and FMEA, to ensure regulatory compliance.
• Create and maintain critical engineering documentation, CAD models, drawings, and Design History Files (DHFs).
• Collaborate with cross-functional teams (electrical, software, quality, regulatory) and provide technical mentorship to junior engineers.

Requirements

• B.S. or M.S. in Mechanical Engineering or a related field.
• 7–10 years of product development experience, with at least 5 years in medical devices or other regulated industries.
• Proficiency in 3D CAD (e.g., SolidWorks) and PDM systems.
• Strong knowledge of DFM/DFA, GD&T, and mechanical system design.
• Experience with mechanical analysis, verification testing, and reliability engineering.
• Demonstrated experience bringing physical products from concept to market.

Nice to have

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