Engineering Manager, Product Development

Role Overview

Engineering Manager, Product Development (Remote - US)

You will lead an engineering/technical team supporting development of radiation protection wearables within a new division. Reporting to the VP, Product Development Engineering, you will drive delivery of new products, line extensions, and product improvements in collaboration with Marketing Product Managers and cross-functional stakeholders.

Responsibilities

• Manage a team of 2–3 development engineers and technical specialists.
• Drive execution of product development projects across one or more product lines.
• Serve as a subject matter expert on:
  • FDA/21 CFR 820.30 Design Controls
  • ISO 13485
  • ISO 14971 Risk Management
  • Design transfer
• Teach/assist teams on technical, compliance, standards, and specification development.
• Coordinate and analyze testing to support marketing claims.
• Review and approve projects, protocols, drawings, and documentation to ensure accuracy and compliance with internal/external standards.
• Qualify and work with outside design firms, testing labs, and technical consultants.
• Assist with PD strategy and tactics.
• Help discover and articulate unmet customer needs.
• Act as project manager for complex, high-impact product development initiatives (as needed).
• Proactively identify and bring forward new technologies, product concepts, and designs for commercial consideration.

Requirements

• BS in Engineering (Mechanical, Chemical Engineering, or Material Science preferred).
• 8+ years engineering experience in a medical device company.
• 3+ years supervising/managing/leading project teams (direct management of engineers/specialists preferred).
• Significant experience in medical device development under FDA 21 CFR 820.30 Design Controls.
• Significant experience with ISO 13485 and ISO 14971.
• Working knowledge of relevant US and international medical device standards.
• Strong engineering, analytical, and technical capabilities.
• Ability to mentor and develop engineers.
• Demonstrated communication, teamwork, and influence/stakeholder management.

Nice-to-Haves

• Reusable and/or disposable product development experience.
• Electromechanical device experience.
• Experience developing medical devices produced in Asia and/or Mexico.

Location & Travel

• Fully remote within the US.
• Ideally located within 2 hours of client sites in PA and VA and/or willing to travel.
• Travel estimate: 20–30% for at least the first year (also mentions up to 10–15% with occasional travel to Mexico/Asia).