Software Design Assurance Quality Engineer
$102,000–$163,000 year
On-site · Cambridge, Massachusetts, United States
Job Summary
Design Assurance Quality Engineer responsible for leading software design quality activities for cloud-based medical software (SaMD) used in medical monitoring, ensuring regulatory compliance across the lifecycle from design to post-market. Roles include reviewing test and performance data, conducting root cause analyses, developing Software Quality Plans, risk management, post-market analytics, and driving corrective actions. Requires ensuring adherence to global regulations (FDA/IEC 62304/82304, ISO 14971, QMS) and mentoring teams on quality engineering practices. Must collaborate across stakeholders, monitor quality metrics, and identify opportunities for process improvements; onsite in Cambridge, MA with at least 3 days per week in the office. Bachelor's degree required; Agile/SAFe certifications desired; 10% travel may be required.
Required Qualifications
- Bachelor’s Degree in Quality, Computer Science/Engineering or similar
- Minimum 3 years’ experience in FDA regulated medical device/tech software environments (IEC 62304/82304)
- Experience with cloud-based medical software SaMD, Health IT, or EMR
- Proven experience with software quality tools for design traceability and Design for Quality (DfQ)
- Strong knowledge of SDLC and Agile/SAFe practices
- Familiarity with ISO 14971 risk management and regulatory compliance
- Ability to perform root cause analyses and lead corrective actions
- Excellent communication and mentoring skills
- Willingness to travel up to 10%
Desired Qualifications
- Bachelor’s Degree in Quality, Computer Science/Engineering or similar
- 3+ years’ experience in FDA regulated medical device/tech software environments (IEC 62304/82304)
- Experience with cloud-based medical software SaMD, Health IT, or EMR
- Experience with software quality tools for design traceability and Design for Quality (DfQ)
- Agile/SAFe certifications desired
- Experience with ISO 9001 (beneficial) or similar quality management systems
- Strong root cause analysis, quality planning, and regulatory compliance skills
Additional Requirements
- US work authorization required; visa sponsorship not provided
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