Principal Product Development Engineer (Medical Device)

3 Days Old

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 integration of 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 protocol to ensure that engineering verification tests are designed to 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 IP portfolio
Act as a mentor to 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
Track record of moving product from concept to transfer to manufacturing
Experience with cytometry is a plus
Company DescriptionGeneral 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 AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus.Company DescriptionGeneral 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 AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus.
Location:
Watertown

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