The Sr. R&D Engineer position works cross-functionally to lead research and development efforts of complex medical devices.
The position designs, develops and implements new products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.
Design and develop new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.
Develop new processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate.
Write and review product development plans, technical documents and reports. Prepare and approve verification and validation protocols and reports.
Develop new engineering test methods and conduct engineering evaluations for new products and processes.

B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
Demonstrated hands-on technical aptitude.
Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization.
Ability to create and execute project plans.
Ability to lead cross functional teams.
Basic tooling, design and drafting knowledge.
Ability to analyze data, interpret results, and write reports.
Proficient in statistic software.
Training in Six Sigma or Design for Six Sigma.

Senior R&D Engineer

Key skills