Design Engineer II

Design Engineer II

The Design Engineer II supports the development, improvement, verification, and transfer of medical device products within a regulated engineering organization. This role focuses on creating robust product designs, maintaining complete and accurate design documentation, supporting design verification activities, and partnering closely with manufacturing, quality, regulatory, supply chain, and commercial teams. The position is ideal for a hands-on, detail-oriented engineer who thrives in a structured medical device environment and is motivated by developing products that improve patient care.

• Design, develop, and improve medical device products and components from initial concept through production release.
• Create and maintain 3D CAD models, detailed drawings, assemblies, bills of material, specifications, and related engineering documentation.
• Support product development activities including feasibility builds, prototype testing, design reviews, design verification, validation support, and design transfer to manufacturing.
• Develop test methods, write test protocols, execute or coordinate testing, analyze results, and document conclusions in accordance with internal quality system requirements.
• Collaborate with Manufacturing Engineering and Operations to enhance manufacturability, assembly processes, yield, product quality, and scalability.
• Support design changes, engineering change orders, product line extensions, supplier changes, and continuous improvement initiatives.
• Participate in risk management activities including risk analysis, FMEA, mitigation planning, and post-market product support.
• Investigate product performance issues, nonconformances, complaints, and manufacturing challenges using structured problem-solving and root cause analysis tools.
• Work with suppliers and contract manufacturers on component design, manufacturability, specifications, tooling, inspection requirements, and qualification activities.
• Maintain an accurate and complete Design History File and technical documentation to support FDA and other applicable regulatory requirements.
• Apply design for manufacturing and assembly principles to ensure efficient production and high product reliability.
• Contribute to process validation and inspection method development to ensure consistent product quality.
• Communicate technical information clearly to cross-functional stakeholders and participate actively in design and project reviews.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• 2+ years of engineering design or product development experience, preferably within medical device or another regulated industry.
• Proficiency with 3D CAD software such as Solid Works or equivalent.
• Experience creating engineering drawings, tolerance schemes, assembly documentation, and technical specifications.
• Working knowledge of design controls, verification testing, documentation practices, and structured engineering change processes.
• Strong mechanical aptitude with the ability to support hands-on prototyping, troubleshooting, testing, and manufacturing support.
• Ability to work effectively in a cross-functional environment and collaborate with manufacturing, quality, regulatory, supply chain, and commercial teams.
• Clear and concise communication skills for presenting technical information to diverse stakeholders.
• Experience with mechanical design, CAD, and 3D modeling in support of new product development.
• Understanding of medical device development practices and quality systems in a regulated environment.

• Medical device product development experience, particularly with Class I or Class II devices.
• Experience with endoscopy, visualization systems, minimally invasive devices, catheters, small electromechanical assemblies, or disposable and reusable devices.
• Knowledge of FDA Quality System Regulation and relevant ISO standards, including usability, sterilization, biocompatibility, and regulatory submission support.
• Experience designing plastic, machined, molded, stamped, or miniature precision components.
• Familiarity with design…