Gravitas Medical is developing a novel sensor enabled nasogastric feeding tube that is positioned to change the standard of care for enteral feeding.
This position provides design and development support for new products, as well as manufacturing and sustaining support of established product lines. The candidate will work well with cross-functional teams to identify and develop design solutions for electrical and electro-mechanical devices that meet product specifications with high reliability, within COGS goals, and company timelines. Specifically, this position will perform all aspects of electronic and firmware design and development from the initial feasibility stage, product development, clinical use, regulatory clearance, and commercial launch. This position requires a high level of technical skill in the areas of embedded software, schematic design, analysis, PCB layout, PCBA design, and board & system level performance testing. This position will be responsible for leading development efforts including all planning, scheduling, and documentation required per design controls. This position requires the ability to work as part of a team or to be able to lead a small team. This position will interface with component vendors, PCB/PCBA fabrication houses, and test agencies. This position requires strong communication skills: verbal, presentations, and technical report writing.
Skills & Experience - Required
· BSEE or equivalent
· 10+ years of experience in the development of medical devices
· Design and development of electromechanical systems, including analog and digital circuits
· Electronic design principles & simulation, schematic, board design, C programming and embedded software
· Proven track record of rapid and efficient product development and breadboarding
· Development within FDA regulated medical device design controls: SRS, SDD, Software Validation, & FMEA
· ISO 13485, FDA QSR, IEC 60601, and IEC 62304
· Principle EE of multiple projects having received FDA clearance.
· DFM: Responsible for product manufacturing at Qty > 10k units, including manufacturing quality controls.
Skills & Experience - Preferred
· Supported commercially launched medical products
· Responsible for design transfer to contract manufacturer.
· nRF51, PIC
· BLE protocols