Drawbridge Health is seeking an experienced, versitile and hands-on component design and systems integration engineer with a passion for developing and commercializing transformative medical diagnostics and devices. Reporting dirctly to the company's Senior Director of Product Development, the Principle R&D Engineer will lead a multi-faceted design and development effort that integrates proprietary technology developed by GE Research into a paradigm-shifting sample collection and stabilization platform for both the US and global markets. S/he will ensure that all aspects of the product and considered and integrated as a whole. S/he will work closely with internal and external bioscience and engineering experts to develop a product that can be verified and validated successfully as a system meeting the marketing, clinic, quality, regulatory, or other requirements.
The ideal candidate will have a proven track record of designing and delivering world-class medical device and/or diagnostic products.S/he will couple an entrepreneurial, hands-on approach with best-practice design and development processes learned in previous roles at successful companies to deliver outstanding products on sggressive timelines. The successful candidate will be able to think out-of -the-box and implement effective product development processes and will hve strong organizational skills and the ability to bring a sense of urgency to all high priority activities. S/he will need to also understand user needs and sample collection and diagnostics workflows and processes to fully realize a seamless user experience. S/he will have formal experience working with an internal quality system, design controls, and regulartory experts to bring products through FDA clearence.
Develop and deliver high quality, innovative diagnostics/medical devices, taking conception through manufacturing, testing, regulatory approval and market launch.
Partner with technical leadership and key customer to identify user needs and translate needs into design requirements and technical specifications. Key customers include patients, healthcare providers and clinical diagnostics lab staff.
Oversee design, prototyping and development of device system components to meet customer needs.
Partner with technology and component experts to integrate, evaluate and modify component and system designs to meet overall user requirements.
Identify, develop and validate bench and design verification test method
Collaberate with technical leadership to identify pre-clinical research needs and lead in vivo pre-clinical studies
Partner with regulatory/quality and other team members to prepare regulatory submissions
Collaborate with manufacturing team members or contract manufacturers in transferring design from development to steady-state production
Connect cross-functional team members and partners across product marketing/ user experience, science/engineering, clinical/ regulatory/ quality, and supply chain/ manufacturing to developer product