Sr. R&D Engineer, Products

Position: Sr. R&D Engineer, New Products
We are seeking a Sr. R&D Engineer, New Products to lead the research, design, development, and launch of innovative medical devices from concept through commercialization. In this role, you will partner closely with cross-functional teams across R&D, Product Management, Clinical, Quality, Regulatory, and Operations to identify unmet needs, evaluate new technologies, develop and test prototypes, and translate insights into robust product solutions.

This is a hands-on engineering role for someone who thrives in fast-paced product development environments and enjoys solving complex technical challenges from early feasibility through product launch and post-launch improvement.

* Lead product development work streams 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