Role Description

We are seeking an Engineering Manager, Product Development to lead a technical team focused on the development of innovative radiation protection wearable products used in healthcare settings. This role is responsible for driving new product development, product enhancements, and line extensions aligned with business strategy. The position works closely with cross-functional partners including marketing, quality, and operations to bring products from concept through commercialization.

This is a fully remote position within the US with a preference for candidates located in the Eastern region, ideal within driving distance of Pennsylvania or Virginia sites. Travel is expected to be approximately 20–30% during the first year.

Key Responsibilities

• Lead and manage a team of development engineers and technical specialists.
• Drive execution of product development initiatives across multiple product lines.
• Ensure compliance with FDA Design Controls, ISO 13485, and ISO 14971 Risk Management throughout the development lifecycle.
• Oversee development activities including specifications, design documentation, testing protocols, and validation activities.
• Coordinate testing and analysis to support product performance and marketing claims.
• Partner with marketing and commercial teams to identify unmet customer needs and translate them into product solutions.
• Collaborate with external design firms, testing labs, and technical consultants as needed.
• Provide technical mentorship and leadership to engineering team members.
• Contribute to product development strategy, innovation initiatives, and technology evaluation.
• Manage or support complex development projects as needed.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Material Science, or related field.
• 8+ years of engineering experience within a medical device company.
• 3+ years of leadership experience, including managing engineers or leading project teams.
• Strong experience with medical device development under FDA 21 CFR 820.30 Design Controls, ISO 13485, and ISO 14971.
• Experience with both disposable and reusable medical device products preferred.
• Working knowledge of U.S. and international regulatory and product standards.
• Strong analytical, technical, and project management skills with the ability to lead cross-functional teams.
• Excellent communication and mentoring abilities.
• Ability to travel domestically and internationally as needed.