Principal Product Development Engineer - medical device

Job Description General Fluidics is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology, and immunoassays from human and animal blood ( https://www.generalfluidics.com ). We are creating an entirely new category of blood testing technology that brings the quality and menu of the reference laboratory to the point of care. Our Axess diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry, and immunoassay test menus. We are searching for a highly collaborative and results-driven Principal Mechanical Engineer with a focus on system integration. Responsibilities: Demonstrate leadership by contributing to strategic engineering discussions, aligning solutions with broader business goals, and mentoring team members through knowledge sharing and guidance. Design and integrate systems involving: Optics, Fluidics, Robotics, Real-time data processing, and Software. Lead Axess product development following a stage-gate approach, interfacing with Contract Manufacturing Organizations (CMOs). In collaboration with the team, establish requirements and lead design verification and validation. Continuously evaluate and optimize the system architecture to enhance performance and scalability. Collaborate with cross-functional teams to define precise technical requirements for both hardware and software components. Develop innovative design approaches to address complex engineering challenges and meet product specifications. Work closely with external consultants to leverage specialized knowledge and expertise. Review test protocols to ensure engineering verification tests rigorously assess product performance. Diagnose and resolve technical problems efficiently to minimize downtime and impact on product development. Actively participate in identifying, protecting, and strengthening the company's IP portfolio. Mentor junior engineers and other team members as needed. Desired experience: B.Sc. or M.Sc in Mechanical Engineering and 10+ years of experience in product development in the biotechnology or medical device industry. Demonstrated track record of team and people leadership. Experience in moving products from concept to transfer to manufacturing. Experience with cytometry is a plus. Company Description: General Fluidics is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology, and immunoassays from human and animal blood ( https://www.generalfluidics.com ).

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