Software Quality Assurance Engineer
About The Role
The Principal Software Quality Assurance Engineer at Solventum plays a vital role in ensuring the integrity, safety, and quality of medical device software throughout its lifecycle. This position involves leading comprehensive software assurance activities, including developing quality assurance plans, assessing software safety classifications, and managing software release readiness. The engineer will be responsible for maintaining traceability from system-level requirements down to detailed design, implementation, and testing phases, ensuring compliance with regulatory standards such as FDA, EU MDR, ISO 13485, and IEC 62304. As a key member of the software team, the role requires active participation in configuration audits, review and approval of requirements, design documents, test procedures, and results, as well as providing critical insights into project status and quality metrics. The engineer will act as a quality champion, supporting processes related to CAPA, cybersecurity risk management, and overall software quality assurance.
Qualifications
- Master’s degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science (completed and verified prior to start)
- Five (5) years of experience in software quality assurance within medical device, aerospace, or automotive industries
- Or Bachelor’s degree in relevant fields with seven (7) years of experience in software quality assurance
- Working knowledge of medical device regulations (FDA, EU MDR) and standards (ISO 13485, IEC 62304, IEC 81001-5 series)
- Experience developing and testing software systems, including SaMD, SiMD, and embedded software
- Proficiency in creating and maintaining detailed documentation and test artifacts
- Knowledge of software engineering best practices; familiarity with C language preferred
- Experience with embedded systems, IoT, Bluetooth, Wi-Fi, and cellular technologies
- Excellent verbal and written communication skills, with strong problem-solving capabilities
- Able to manage multiple priorities in a dynamic environment
- Effective interpersonal skills for collaboration with cross-functional teams and external partners
Responsibilities
- Lead software assurance activities throughout the medical device software lifecycle, including developing quality assurance plans and determining safety classifications
- Ensure software traceability from system requirements to design, implementation, testing, and validation phases
- Conduct and oversee configuration audits, reviews, and approvals of software requirements, designs, test procedures, and test results
- Maintain compliance with applicable regulatory requirements and industry standards, performing gap assessments as needed
- Identify and elevate critical issues related to patient safety, cybersecurity, usability, or regulatory adherence
- Act as a quality champion within software development and testing teams, promoting best practices and continuous improvement
- Support quality processes such as CAPA, cybersecurity risk management, and other related initiatives
- Collaborate with cross-functional teams to ensure timely delivery of compliant and safe software products
- Provide insights and metrics on software quality status to management and stakeholders
- Participate in audits, inspections, and regulatory submissions related to software quality
Benefits
- Competitive salary range of $124,000 - $170,500, commensurate with experience and qualifications
- Comprehensive health benefits including medical, dental, and vision coverage
- Health Savings Accounts (HSAs) and Flexible Spending Accounts (FSAs) for healthcare and dependent care
- Disability and life insurance coverage
- Retail plans and savings programs
- Paid time off, holidays, and flexible work arrangements
- Relocation assistance (where applicable)
- Opportunities for professional development and continuous learning
Equal Opportunity
Solventum is an equal opportunity employer committed to fostering an inclusive workplace. We do not discriminate against any applicant or employee based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic. All qualified applicants will receive consideration for employment without regard to these factors. We encourage diverse talent to join our team and contribute to our mission of transforming healthcare through innovation and compassion.