Suntra MedTech Solutions · 1 week ago
Senior Mechanical Engineer - Medical Devices
Bedford,NH,US
Full-time
Onsite
Senior Level
7+ years expSuntra MedTech Solutions is a company focused on developing medical technologies, and they are seeking a Senior Mechanical Engineer to lead the mechanical design and development of medical device components. The role involves overseeing product development from concept through commercialization and collaborating with various teams to deliver integrated products.
Health CareLife ScienceManufacturingMedical Device
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
Qualification
Required
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
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
Company
Suntra MedTech Solutions
At Suntra MedTech Solutions™, we collaborate with visionary medtech leaders to turn pioneering thinking into tangible impact.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Drew Sunstein
Founder / Chairman of the Board
Recent News
2023-12-23
2023-12-23
Medical Design & Outsourcing
2023-12-23
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