Staff Product Development Engineer

Resonetics • Westborough, MA

21h • $118,000 - $171,000

About The Position

The Staff Product Development Engineer leads end-to-end development of complex interventional medical devices in a contract development environment. The role serves as a technical lead for programs delivered on behalf of external clients across a broad range of medical device technologies, owning work from concept generation and detailed CAD design through prototyping, verification, and risk management.

This position requires deep technical expertise, customer-facing communication, and independent resolution of complex, system-level problems. The engineer drives design for manufacturing, quality compliance, and clinical study support; provides technical leadership across multiple projects; mentors junior engineers; and contributes to process improvement and organizational growth.

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.
• Demonstrated ownership, clear communication, and a strong sense of urgency.
• Advanced SolidWorks skills.
• Proficiency in Microsoft Office tools: MS Project, Excel, PowerPoint, Teams, and Outlook.
• Legally authorized to work in the United States without current or future visa sponsorship.

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, including developing 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.

What This Job Offers

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