About This RoleWe are seeking a seasoned Senior Mechanical Engineer to lead the design and development of complex electro-mechanical medical devices. This role is integral to our product development lifecycle, from concept through validation and manufacturing transfer. The ideal candidate will bring deep technical expertise, leadership capabilities, and a passion for innovation in the medical device space.
What You Will Do- May lead the design and development of complex electro-mechanical medical devices and equipment.
- Generate expert-level 3D and 2D CAD data.
- Develop and integrate high-functioning design prototypes with minimal guidance.
- Execute prototype testing plans and ensure compliance with safety standards.
- Provide leadership, training, and mentorship to junior engineers.
- May direct internal resources and manage external development partners.
- May function as the mechanical engineering lead on product development programs.
- Ensure compliance with FDA, QSR, and ISO regulations.
- Participate in business development activities, including proposal review and client engagement.
- Translate Client needs, user insights, and clinical requirements into innovative, feasible, and complaint product concepts.
- Drive system-level design and integration across mechanical, electrical, software, and human factors disciplines.
- Develop, prototype, and iterate design solutions quickly, leveraging hands-on experimentation and engineering analysis.
Required Qualifications- Bachelor's degree in Mechanical Engineering.
- 3-6 years of relevant work experience in medical device development.
- Thorough knowledge of product development and strong understanding of the medical device industry.
- Excellent written and oral communication skills.
- Strong analytical and conceptual skills with the ability to build functional prototypes.
- Ability to solve moderate to complex technical problems.
- Ability to solve problems of diverse scope.
- Exercises judgment in selecting methods and techniques for obtaining solutions.
- Strong ability to manage multiple tasks and projects effectively.
- Familiarity with FDA, QSR, and ISO standards.
- Ability to work independently with minimal guidance.
Preferred Qualifications- Experience leading cross-functional teams and managing external partners.
- Prior involvement in business development or input to proposals.
- Advanced CAD proficiency and rapid prototyping experience.
- Participation in audits and inspections for medical device projects.
Location - This is a hybrid position based in Providence, RI OR Minneapolis, MN
