Staff Product Development Engineer

Resonetics; Westborough (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Resonetics, a global leader in advanced engineering and micro manufacturing for the medical device industry, seeks a Staff Product Development Engineer to own end-to-end development of complex interventional devices. You will lead programs for external clients, drive design, prototyping, verification, and risk management, and mentor junior engineers in a fast-paced, quality-focused environment.

Responsibilities include leading multi-project efforts, managing timelines, and collaborating with

Qualifications

• 7+ years in medical device design/development.
• BS in Mechanical or Biomedical Engineering.
• Knowledge of ISO 13485 and audit participation.
• Advanced SolidWorks skills.
• Experience with catheter-based or minimally invasive devices preferred.
• Proficient with MS Project, Excel, PowerPoint, Teams, Outlook.

Responsibilities

• Lead end-to-end medical device development programs across multiple projects.
• Serve as technical and project lead for customer engagements, driving meetings, proposals, schedules, and decisions.
• Design, prototype, test, and verify device concepts with fixtures and study protocols.
• Own design controls activities including requirements, risk, verification, and QA compliance.
• Mentor junior engineers and promote CAD best practices in SolidWorks.
• Break down complex system challenges into actionable plans with minimal oversight.

Skills

Ownership

Clear communication

Strong sense of urgency

Mentorship

Project leadership

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Tools

SolidWorks

MS Project

Excel

PowerPoint

Teams

Outlook

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Staff Product Development Engineer will lead the end-to-end development of complex, interventional medical devices within a contract development environment, serving as a technical lead for programs executed on behalf of external clients across a broad range of medical devices technologies. This role owns activities from concept generation and detailed CAD design through prototyping, verification, and risk management. It requires deep technical expertise, strong customer-facing communication, and the ability to independently solve complex, system-level problems while driving design for manufacturing, quality compliance, and clinical study support. The engineer will provide technical leadership across multiple projects, mentor junior engineers, and actively contribute to process improvement and organizational growth.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Leads end-to-end medical device development programs, owning scope, timelines, technical execution, risk management, and delivery across multiple concurrent projects.
• Serves as technical and project lead for customer engagements, driving meetings, proposals, schedules, and decision-making while identifying unmet client needs and new technology opportunities.
• Designs, builds, and evaluates device concepts through hands‑on prototyping and rigorous testing, including development of fixtures, test methods, study protocols, and technical reports.
• Owns design controls activities, including requirements development, risk analysis, verification strategies, and compliance with Quality System and product development process requirements.
• Demonstrates advanced SolidWorks proficiency to execute and review complex models and assemblies, while coaching junior engineers on best practices in CAD and design intent.
• Breaks down complex system‑level challenges into actionable plans, independently driving progress with minimal oversight and escalating strategically when needed.

Required Qualifications

• 7+ years' experience in the medical device design/development field.
• Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or an equivalent.
• Strong understanding of ISO 13485, sufficient to participate in an audit and/or guide junior engineers.
• Demonstrates ownership, clear communication, and a strong sense of urgency.
• Advanced SolidWorks skills.
• Experience in catheter-based or minimally invasive device development strongly preferred.
• Proficient in Microsoft Office: MS Project, Excel, PowerPoint, Teams, Outlook.

Physical Demands

• Ability to stand and walk for short periods of time during prototyping, testing, and collaboration activities.

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $120,000-150,000

Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.