Senior Systems Engineer (IVD)
Location: Dublin
Posted on: June 23, 2025
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Job Description:
Senior Systems Engineer (IVD) Location: Pleasanton, CA Duration:
6 months, extendable Onsite Position - must be local Summary: This
Senior Systems Engineer will be part of the System Development team
focusing on the development of novel IVD automated systems and
end-to-end product solutions. The individual is expected to provide
technical and process expertise in collaboration with internal
stake holders and cross functional teams throughout total product
development lifecycle to develop and maintain medical device
products, according to customer requirements, applicable regulatory
and quality standards. This role is expected to lead and mentor
less experienced engineers and their career development.
Responsibilities: Provide technical expertise to cross-functional
teams to develop IVD systems and ensure the product design will
meet customer requirements as well as applicable standards and
regulations; Develop and manage systems level product requirements;
Perform product risk management activities; Develop and execute
verification/validation activities and traceability analysis;
Create artifacts required for project deliverables; Resolve issues
found according to company's defect/change tracking process;
Maintain knowledge of current regulatory requirements and standards
as they pertain to the development and testing of medical/IVD
devices; Maintain compliance as required by regulatory bodies and
the company's quality system; Collaborate with cross functional
teams to identify opportunities for continuous process improvement;
Lead and mentor less experienced Systems Engineers; Support FDA and
other regulatory submission and audits; Who you are You're someone
who wants to influence your own development. You're looking for a
company where you have the opportunity to pursue your interests
across functions and geographies. MUST-HAVE Qualifications:
Bachelor's degree in Systems Engineering, Biomedical Engineering,
Electrical Engineering or related disciplines. Advanced degree
preferred; 5 years of professional experience in medical device
industry. Experience in IVD industry highly desirable; Hands-on
experience with liquid pipetting systems such as Hamilton, Tecan
etc. is a plus; Experience developing product requirements and
design inputs; Experience conducting risk management activities per
ISO 14971; Strong analytical, problem solving, communication, and
interpersonal skills;
Keywords: , San Bruno , Senior Systems Engineer (IVD), Engineering , Dublin, California
