Staff Product Development Engineer

Resonetics • Westborough, MA

9h • $120,000 - $150,000

About The Position

The Staff Product Development Engineer leads end-to-end development of complex interventional medical devices in a contract development environment, serving as technical lead for programs delivered to external clients across a broad range of medical device technologies. The role owns development from concept generation and detailed CAD design through prototyping, verification, and risk management, while supporting design for manufacturing, quality compliance, and clinical studies.

The engineer provides technical leadership across multiple concurrent projects, works directly with customers, mentors junior engineers, and contributes to process improvement and organizational growth. The position requires deep technical expertise, strong customer-facing communication, and independent resolution of complex system-level problems.

The anticipated compensation range is $120,000–$150,000, based on experience and qualifications. Visa sponsorship is not available; candidates must already be legally authorized to work in the United States without sponsorship now or in the future.

Requirements

• At least 7 years of experience in medical device design and development.
• Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or an equivalent field.
• Strong understanding of ISO 13485, sufficient to participate in an audit and/or guide junior engineers.
• Advanced SolidWorks skills.
• Proficiency with Microsoft Office applications: MS Project, Excel, PowerPoint, Teams, and Outlook.
• Demonstrated ownership, clear communication, and a strong sense of urgency.
• Must already be legally authorized to work in the United States without visa sponsorship now or in the future.

Nice To Haves

• Experience in catheter-based or minimally invasive device development is strongly preferred.

Responsibilities

• Lead end-to-end medical device development programs, owning scope, timelines, technical execution, risk management, and delivery across multiple concurrent projects.
• Serve as technical and project lead for customer engagements, driving meetings, proposals, schedules, and decision-making while identifying unmet client needs and new technology opportunities.
• Design, build, and evaluate device concepts through hands-on prototyping and testing; develop fixtures, test methods, study protocols, and technical reports.
• Own design controls activities, including requirements development, risk analysis, verification strategies, and compliance with Quality System and product development process requirements.
• Use advanced SolidWorks skills to execute and review complex models and assemblies, and coach junior engineers on CAD best practices and design intent.
• Break down complex system-level challenges into actionable plans, independently drive progress with minimal oversight, and escalate strategically when needed.
• Mentor junior engineers and contribute to process improvement and organizational growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior