Sr. Mechanical Engineer - Medical Devices

Senior Mechanical Engineer - Medical Devices

Description

Looking to bypass the grinding daily commute into Boston/Cambridge and still work on the most innovative new technologies in healthcare?

We develop new medical technologies, including work with MIT on ingestible sensing, and programs involving artificial-womb technology, surgical robotics, and implanted cardiac assist devices. Our Engineers work across a variety of ambitious development programs with a collaborative engineering culture and flexible hybrid working environment, one day per month (on average) in our state-of-the-art facility in Bedford, NH. We design products with our clients and then move on to designing the the next new and exciting product.

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

Qualifications

• 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 system design.
• 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.

Preferred Experience

• Class II or Class III medical device experience is preferred, but we will gladly look at standout mechanical talent from other safety-critical compliance sectors (e.g., Aerospace, Defense, Robotics).
• Fluidics, micro-mechanisms, or disposable device design.
• Hands-on prototyping and test fixture development.
• Exposure to project management tools and agile development methodologies.