General Fluidics
Principal Mechanical Engineer
General Fluidics, Waltham, Massachusetts, United States, 02254
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
Job Type: Full-time
Benefits:
Dental insurance
Health insurance
Paid time off
Schedule:
Monday to Friday
Work Location: In person
#J-18808-Ljbffr
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
Job Type: Full-time
Benefits:
Dental insurance
Health insurance
Paid time off
Schedule:
Monday to Friday
Work Location: In person
#J-18808-Ljbffr