Product Development Engineer III

Job Summary:

Product Development Engineer III applies advanced engineering principles and medical device product development expertise to develop and support Surgical Navigation products from concept through commercialization. This role is responsible for planning and executing engineering activities within our product development process, including design documentation, verification and validation, prototype and production-intent builds, and cross-functional project execution.

This role works independently on complex technical assignments and collaborates with both our external customers and internal Quality, Regulatory, Operations, Commercial Team and Supply Chain teams to ensure product requirements are met while maintaining compliance with design control and quality system requirements. It requires strong technical judgment, problem-solving skills, and the ability to drive project deliverables with limited supervision.

Job Duties and Responsibilities:

Product Development

• Lead the design, development, and optimization of Medical Device & Surgical Navigation products, components, assemblies, and subsystems from concept through commercialization.
• Translate customer, user, and clinical needs into product requirements, engineering specifications, and design inputs.
• Perform concept development, feasibility assessments, risk analyses, and design reviews.
• Coordinate prototyping, testing, and analysis activities to assess product performance and reliability.
• Evaluate design alternatives and implement solutions that optimize performance, reliability, manufacturability, and usability.
• Troubleshoot complex technical challenges and drive effective resolutions.
• Support Voice of Customer (VOC) activities and apply market and clinical insights to product development.
• Ensure compliance with applicable medical device regulations, design controls, risk management processes, and quality system requirements.

Engineering Documentation

• Create and maintain engineering documentation including CAD models, drawings, GD&T specifications, BOMs, product specifications, test protocols, test reports, and DHF deliverables.
• Ensure documentation is complete, accurate, and compliant with quality system requirements.
• Support design verification and validation activities through timely and thorough documentation.

Design Verification & Validation

• Develop and execute verification and validation strategies, plans, protocols, and reports.
• Define test methods, acceptance criteria, and data collection approaches to demonstrate compliance with product requirements.
• Analyze test results, resolve identified issues, and present findings during technical and design reviews.

Verification & Validation Builds

• Coordinate prototype, engineering, and production-intent builds.
• Partner with Operations, Manufacturing Engineering, Supply Chain, and Quality to ensure build readiness and successful execution.
• Track build outcomes, document findings, and drive issue resolution.

Cross-Functional Collaboration

• Collaborate with Quality, Regulatory, Clinical, Marketing, Manufacturing, Supply Chain, Program Management, and Operations teams to achieve project objectives.
• Support design transfer, manufacturing readiness, and product launch activities.
• Communicate project status, technical risks, and mitigation plans to stakeholders.

Contribute to continuous improvement initiatives that enhance product quality and development efficiency

Qualifications

Required

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of product development experience, preferably in the medical device industry.
• Experience developing mechanical and/or electromechanical products in a regulated environment.
• Strong knowledge of design controls, risk management, and regulated product development processes.
• Expertise in product design, DFx, materials selection, manufacturing processes, and mechanical problem-solving.
• Experience creating engineering documentation, including drawings, specifications, BOMs, DHF deliverables, and verification/validation documentation.
• Proficiency with SolidWorks or similar 3D CAD software, including GD&T and engineering drawing creation.
• Experience with prototyping, verification and validation testing, root-cause analysis, and technical troubleshooting.
• Strong technical writing, analytical, and problem-solving skills.
• Proficiency with Microsoft Office Suite.
• Ability to independently manage technical work and collaborate effectively within cross-functional teams.
• Experience supporting FDA submissions, including 510(k) and/or PMA programs.

Preferred

• Experience developing Surgical Navigation, image-guided surgery, or capital medical equipment products.
• Medical device manufacturing experience.
• Knowledge of FDA QSR, ISO 13485, IEC 60601, and other applicable medical device standards.
• Experience supporting design transfer and manufacturing readiness.
• Experience with machine shop operations, injection molding, and additive manufacturing.
• Familiarity with requirements management, FMEA, statistical analysis, Microsoft Project, and Minitab.

 Salary: $85,000-$115,000