Software Design Assurance Eng
$102,480–$163,968 year
On-site · Bedford, Massachusetts, United States
Job Summary
Software Design Assurance Engineer focused on leading assessment of software designs, reviewing test and performance data to uphold quality, safety, and regulatory standards across the software lifecycle. Drive software design verification/validation, risk management, traceability, cybersecurity risk management, and compliance with policies and practices. Author and execute software test protocols, manage post-market analytics, initiate corrective actions, and oversee regulatory planning and filings for global registrations to enable timely market access. Requires 5+ years in FDA-regulated IEC 62304 environments, a Bachelor's degree, and strong knowledge of SDLC and QMS related to Software Design Controls. On-site role at Philips Bedford, MA with in-person work 3 days per week; ISTQB certification is desirable. Headcount aligns with on-site collaboration and regulatory excellence across the product software lifecycle.
Required Qualifications
- Bachelor’s Degree in Quality, Computer Science/Engineering or similar disciplines
- 5+ years in FDA-regulated, IEC 62304 medical device software environments
- Experience in Software Design Assurance/Control, Risk Management (ISO 14971), SDLC
- Knowledge of Software Design/Verification, software testing and validation
- Strong root cause analysis, software V&V, design traceability
- Ability to interpret software design and code (C/C++/C# or OO language)
- ISTQB certification desired
- Excellent written and verbal communication skills
- Ability to work on-site with 3 days/week in the office
- Regulatory planning and submission experience for global registrations
- Ability to travel up to 10%
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