Job Description:
Principal Software Quality Assurance Engineer
3M Health Care is now Solventum
At Solventum , we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum , we never stop solving for you.
The Impact You’ll Make in this Role
As a Principal Software Quality Assurance Engineer , you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
- Leading software assurance activities throughout medical device software life cycle, including creating software quality assurance plan, determining software safety classification, software test readiness, software release readiness. Responsible for ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing.
- Being an active member of the software team during the whole software life cycle, with responsibility for physical and functional configuration audits, reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics.
- Ensuring compliance with applicable regulatory requirements and industry standards; performing gap assessments; immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements
- Acting as a quality champion in software product development and testing teams
- Supporting other software related processes such as CAPA process, and other quality related processes regarding cybersecurity risk management and software quality assurance.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following 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) and five (5) years of experience in software quality assurance in medical de