Senior Software DQA Engineer

Job Description The Senior Software DQA Engineer supports risk-based design assurance for medical device software, partnering closely with R D to ensure products are safe, compliant, and aligned with regulatory standards throughout development. This is not a hands-on coding or testing role, but rather focused on reviewing software, system design, and documentation to identify risks (especially cybersecurity) and drive mitigation strategies. The role sits in a "gray area" between software, quality, and cybersecurity, helping ensure software meets requirements across complex systems (software, hardware, firmware).

Day-to-day responsibilities include:

Reviewing software, code, and system design to identify risks, bugs, and cybersecurity vulnerabilities Partnering with R D to ensure software is compliant and built correctly throughout the SDLC Supporting design reviews, test strategy discussions (unit, regression, automation), and system-level validation Identifying and tracking risks (DFMEA, hazard analysis, security risk assessments) and driving mitigation Ensuring documentation aligns with regulatory standards and supporting audit readiness Troubleshooting issues and driving root cause analysis for quality concerns Helping define software safety levels and requirements for regulated products

Compensation:

$60/hr to $68/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• Bachelor's degree in Electrical Engineering, Software Engineering, or related field
• 5+ years of experience in a regulated medical device environment
• Hands-on experience with medical device software (embedded systems, applications, or SaMD)
• Experience identifying and mitigating cybersecurity risks within product development
• Experience working across integrated systems (software, hardware, firmware)
• Strong understanding of FDA, ISO, and EU MDR regulations
• Familiarity with key standards including 21 CFR Part 820, ISO 13485, IEC 62304, and

ISO 14971

• Ability to review (not develop) code, requirements, and documentation to identify gaps and risks
• Strong communication and collaboration skills with R D teams
• Master's degree in electrical or software engineering
• Experience with Medical Electrical Equipment (MEE)
• Additional years of experience in regulated medical device environments
• Experience working with legacy systems or gap remediation (ex: older platforms with evolving requirements)
• Familiarity with tools/environments such as Jira, Linux, or similar development ecosystems