Job Overview
Lead an engineering team to drive product development projects for medical devices, including new products, line extensions, and improvements. Report to the VP of Product Development Engineering, manage both on-site and remote associates, and collaborate with cross-functional leaders to align with business strategy. Participate in strategic planning and budgeting, with 20-30% travel estimated for the first year.
Responsibilities
- Manage a team of 2-3 development engineers and technical specialists.
- Drive execution of product development projects across TIDI product lines.
- Serve as subject matter expert on FDA and ISO Design Controls, Risk Management, and Design Transfer; support other Quality Management Systems functions.
- Teach and assist on technical, compliance, standards, and specification development.
- Coordinate, analyze, and supervise testing to support marketing claims.
- Review and approve projects, protocols, drawings, and documentation for accuracy and compliance with standards.
- Qualify and engage outside design firms, testing labs, and technical consultants.
- Assist in developing product development strategy and tactics.
- Help discover and articulate unmet customer needs.
- Act as project manager for complex and impactful projects as necessary.
- Identify and propose new technologies, product concepts, and designs to the commercial team.
- Demonstrate support for company mission, vision, values, and behaviors; perform other tasks as required.
Qualifications
- BS Degree in Engineering (Mechanical, Chemical Engineering, or Material Science preferred).
- 8 years experience as an engineer in a medical device company.
- 3 years experience supervising, managing, and/or leading project teams; some direct management of engineers and/or technical specialists preferred.
- Significant experience in medical device development under FDA 21 CFR 820.30 Design Controls, ISO 13485, and ISO 14971 Risk Management.
- Experience with both reusable and disposable product development strongly preferred; some electromechanical device experience preferred.
- Working knowledge of U.S. and international standards applicable to medical device development.
- Experience developing medical devices produced in Asia and/or Mexico preferred.
- Strong engineering, analytical, and technical skills.
- Demonstrated ability to mentor and develop engineers.
- Demonstrated effective communication skills.
- Successful team player with interpersonal and influence management skills.
- Track record of successful collaboration with multiple stakeholders.
