About This Role
We 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.

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