Base: $61,300.00 – $122,700.00; bonus/equity: not ...
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2-5 years software design quality experience
Agile sdlc framework knowledge
Fda regulations and iso 13485 compliance
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Abbott is seeking a Software Design Quality Engineer to join their Vascular division in Westford, Massachusetts. This onsite role involves leading quality engineering deliverables throughout the product lifecycle, with a focus on software design quality and regulatory compliance.
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Job Summary
Abbott is a global healthcare leader seeking a Software Design Quality Engineer to support the Vascular division in Westford, MA.
The role involves leading quality engineering deliverables from product concept through commercialization while ensuring compliance with FDA regulations and ISO standards.
Employees enjoy comprehensive benefits including free medical coverage, high employer retirement contributions, and tuition reimbursement programs.
Matching Summary
Match Score: 75
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Abbott is seeking a Software Design Quality Engineer to join their Vascular division in Westford, Massachusetts. This onsite role involves leading quality engineering deliverables throughout the product lifecycle, with a focus on software design quality and regulatory compliance.
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Salary
Base: $61,300.00 – $122,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
2-5 years software design quality experience
Agile SDLC framework knowledge
FDA regulations and ISO 13485 compliance
Risk management activities like FMEA
CAPA management and root cause analysis
Jira and Jama requirements tools usage
Nice-to-have
Master's level degree in related field
ASQ CSQE and ISTQB certifications
Experience with TestComplete tool
Code review static analysis tools
Programming experience in C/C#/Java
Clinical or hospital experience
Key Requirements
Bachelor's degree in Computer Science or Biomedical Engineering
Minimum 2-5 years combined experience in software design quality
Deep knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485