Sr Mechanical Engineer

About the 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.

Responsibilities

• 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 compliant 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.

Requirements

• 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.

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.