Medical Device Software Quality Engineer (Onsite)

RXinsider LTD.

Westford (MA)

On-site

USD 61,000 - 123,000

Full time

14 days+

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Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Software Design Quality Engineer for the Vascular division at its Westford, MA site. This fully onsite role focuses on delivering medical device software quality throughout the product lifecycle.

The candidate will lead quality engineering activities, support risk assessments, and ensure regulatory compliance across design and testing processes. Abbott offers competitive benefits and career growth.

Qualifications

Bachelor level degree in Computer science, biomedical engineering, software engineering or related field.
Minimum of 2-5+ years of experience in software design quality and cybersecurity design quality.
Experience with automation frameworks and scripts meeting design control requirements.
Experience with software config/issue tracking tools such as Jira and Jama.
Experience in Agile SDLC projects/programs.

Responsibilities

Lead, execute and support on-time quality engineering deliverables from concept through commercialization, incl. RMF, FMEA, Cybersecurity Risk Assessment.
Support on-time execution of Quality Plans.
Guide development of SOPs, specs and test procedures.
Support product recertifications.
CAPA management with root-cause analyses and corrective actions.