Product Development Engineer (Medical Device)

Overview

A highly specialized contract design and manufacturing partner in the medical device industry is seeking a Product Development Engineer to support the development of next-generation minimally invasive technologies.

This organization partners with leading medical device companies to bring complex catheter-based products from early concept through design, prototyping, and full-scale manufacturing. Their engineers work hands-on across the full product lifecycle—making this an ideal opportunity for someone who thrives in fast-paced, highly technical, and collaborative environments.

Unlike traditional OEM roles, this position offers exposure to a wide range of technologies, customers, and product development challenges.

Key Responsibilities

Product Development & Technical Leadership

  • Lead development of complex components, assemblies, and processes from concept through commercialization
  • Drive design strategy within assigned workstreams and contribute to overall product architecture
  • Perform feasibility studies, risk analyses, and system-level trade-offs
  • Design and develop advanced test methods, fixtures, and tooling

Verification, Validation & Compliance

  • Lead verification and validation (V&V) planning and execution
  • Analyze and synthesize data, producing clear and thorough technical documentation
  • Ensure compliance with design controls, quality systems, and regulatory standards
  • Support design transfer activities including manufacturing collaboration and process validation

Cross-Functional Collaboration

  • Partner with Quality, Regulatory, Manufacturing, and external suppliers throughout development
  • Present technical findings and updates to internal stakeholders and customers
  • Participate in client-facing discussions, helping translate clinical needs into engineering solutions

Innovation & Prototyping

  • Drive rapid prototyping and iterative design improvements
  • Contribute to the development of catheter-based systems, including shafts, balloons, and extrusion-based components
  • Solve complex design challenges in a fast-paced, evolving environment

Mentorship & Team Contribution

  • Mentor junior engineers and support development of engineering best practices
  • Lead portions of technical workstreams and contribute to overall team success

Qualifications

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field
  • 2+ years of experience in medical device product development
  • Strong understanding of design controls, quality systems, and regulatory standards
  • Proficiency in SolidWorks and mechanical design fundamentals (GD&T, tolerance stack-ups, etc.)
  • Experience developing test methods, fixtures, and prototypes
  • Strong analytical and problem-solving skills

Preferred Qualifications

  • Experience with catheter systems, extrusion, reinforced shafts, or steerable devices
  • Background in minimally invasive or interventional medical devices
  • Experience with statistical tools (Minitab, DOE, regression, capability analysis)
  • Proven ability to lead technical workstreams and drive design decisions

Why This Opportunity?

  • Work on cutting-edge catheter-based technologies across multiple programs
  • Exposure to the full product lifecycle—from concept through commercialization
  • Highly collaborative, hands-on engineering environment
  • Opportunity to work directly with leading medical device companies
  • Fast-paced setting ideal for engineers who enjoy variety, innovation, and problem-solving

Benefits Highlights

  • Flexible paid time off + company holidays
  • Comprehensive health, dental, and vision coverage
  • HSA with employer contribution
  • Short- and long-term disability coverage
  • 401(k) with company contribution

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