Sr. Product Development Engineer

ResoneticsWestborough, MA
22h$78,000 - $124,000

About The Position

Resonetics is a global leader in advanced engineering, prototyping, product development, and micromanufacturing for the medical device industry. Our AGILE Product Development® team is driven by the guiding principles of quality, urgency, and partnership with our customers and operates in alignment with Resonetics’ core values that emphasize patient centric design, integrity, and innovation. With deep expertise in catheter-based delivery systems, electrophysiology, cryotherapy, and implantable devices, our engineers bring elegant medical solutions to life — supporting programs from early concept and rapid prototyping through validation and commercial scaleup. As we continue to expand across our global footprint, we push the boundaries of technology while fostering a dynamic, employee centered culture focused on innovation and continuous improvement. The Senior 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.

Requirements

  • 5+ years' experience in the medical device design/development field.
  • 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 Teams, Excel, PowerPoint, Outlook.

Nice To Haves

  • Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or an equivalent experience

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.
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