Sr R&D Engineer - Nutritional Delivery/Thermometry
Core
Lead design, development, testing, and refinement of electromechanical medical devices including enteral feeding pumps, thermometers, and compression devices.
Role type
Senior R&D Engineer (Medical Device Product Development)
Builds
Electromechanical medical devices (feeding pumps, thermometers, compression devices)
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features
Required skills
Full lifecycle design control, statistical analysis (ANOVA, regression, Monte Carlo), test method development and validation, regulatory compliance (FDA, ISO 13485), cross-functional project leadership
Preferred skills
LSS Green Belt, DFSS, Minitab/JMP, 2+ years medical device product development experience
Technologies
Minitab, JMP, 21 CFR Part 820.30, ISO 13485
Responsibilities
Drive full lifecycle execution of complex product development projects from concept through commercialization; Troubleshoot and resolve intricate technical issues related to concept designs and products; Design, develop, and validate comprehensive test protocols and methods that comply with FDA and international standards; Create, review, and approve critical project documentation including design specifications and design history file elements; Act as a key technical liaison with internal teams and external stakeholders to ensure seamless project execution; Actively participate in discovering and articulating unmet customer and clinical needs to translate into innovative product requirements
Seniority
Senior, hands-on IC