Product Engineer Jobs

About The Position

Requirements

• 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.
• Must be authorized to work in the United States.

Nice To Haves

• 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.

Responsibilities

• Lead design, development, and optimization of medical device and 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 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 resolutions.
• Support Voice of Customer 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.
• Create and maintain engineering documentation, including CAD models, drawings, GD&T specifications, BOMs, product specifications, test protocols, test reports, and DHF deliverables.
• Ensure engineering documentation is complete, accurate, and compliant with quality system requirements.
• Support design verification and validation through timely, thorough documentation.
• 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 in technical and design reviews.
• 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.
• 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.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401(k) plans
• Time off programs
• Potential eligibility to participate in an annual bonus program, dependent on various factors including individual and organizational performance