What are the responsibilities and job description for the Senior Mechanical Engineer position at Suntra MedTech Solutions?
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.
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. (Owning a complete design - not just a subsystem)
- 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 devices.
- Fluidics, micro-mechanisms, or disposable device design.
- Hands-on prototyping and test fixture development.
- Exposure to project management tools and agile development methodologies.