Sr. R&D Engineer, New Products

About the role

We are seeking a Senior R&D Engineer, New Products to lead the research, design, development, and launch of innovative medical devices from concept through commercialization.

Responsibilities

• Lead product development workstreams from concept through launch, including planning, execution, and cross-functional coordination
• Design, prototype, and evaluate product concepts using biomechanical models, benchtop methods, and experimental testing
• Develop and execute verification and validation activities to assess product performance and design robustness
• Design, build, and verify test hardware, fixtures, and systems, including automation tools, as needed to support product development
• Apply sound mechanical and engineering principles to understand, model, and solve problems involving complex systems
• Perform statistical analysis and interpret data to guide technical decisions and product improvements
• Communicate technical findings, recommendations, and product insights effectively to stakeholders at all levels
• Collaborate with cross-functional partners to incorporate design inputs, technical requirements, and user needs into product prototypes and final designs
• Partner with Clinical Affairs and cross-functional teams to support clinical studies and other product investigations
• Generate clear, complete technical documentation in compliance with FDA, ISO, and internal medical device development requirements, including protocols, reports, and design documentation
• Contribute to invention generation, intellectual property development, and patent disclosures
• Prioritize and execute work effectively in a fast-paced environment with evolving priorities and critical timelines
• Provide broad engineering support as needed

Requirements

• B.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 8+ years of experience in biomedical research and/or product development
• M.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 6+ years of experience in biomedical research and/or product development
• Ph.D. in Mechanical Engineering, Biomedical Engineering, or a related field with 3+ years of experience in biomedical research and/or product development

Preferred qualifications

• Strong theoretical and experimental background in structural mechanics and biomechanics
• Experience with 3D CAD solid modeling and mesh-based modeling tools
• Test method development, verification, and validation
• Data analysis, scripting, and automation for experimental and design workflows
• Additive manufacturing (3D printing) for test fixtures, prototypes, and end-use product applications

Benefits

For a detailed overview of the benefits offered, please refer to the General Description of All Benefits section.