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Principal Mechanical Engineer

ZipRecruiter, Waltham, Massachusetts, United States, 02254


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:

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.

Support System Validation: Contribute to the validation process to verify that the system meets regulatory requirements and intended use.

Actively participate in identifying, protecting, and strengthening the company IP portfolio.

Act as a mentor to junior engineers and other team members as needed.

QUALIFICATIONS:

B.Sc. or M.Sc. in Mechanical Engineering

10+ years of experience in product development in the biotechnology industry

Experience with design and integration of systems involving: Optics, Fluidics, Robotics, Real-time data processing, and Software

Excellent communication skills, verbal and written

Thorough understanding of the product development stage gate process

Demonstrated experience with requirements definition, and design verification and validation

A proven track record of going from concept to transfer to manufacturing

Desire to learn and develop new technologies in a biotech R&D startup

Company Description:

General Fluidics is improving the health of people globally by making the highest quality blood diagnostics more accessible. In collaboration with the Massachusetts General Hospital, General Fluidics has developed a scalable blood and urine diagnostic testing platform that packages critical diagnostic testing technologies in a seamlessly integrated point-of-need benchtop instrument.

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