Staff Software Quality Assurance Engineer

SOLVENTUM

27d • Remote

About The Position

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 Staff 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.

Requirements

• 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 device, aerospace, or automotive industry OR Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security or Information Science (completed and verified prior to start) and seven (7) years of experience in software quality assurance in medical device, aerospace, or automotive industry
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• Working knowledge of premarket and postmarket medical device regulations (FDA, EU and other agencies), as well as medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others.
• Experience developing and testing software systems, SaMD, SiMD, and/or embedded software and creating appropriate documentation
• Knowledge of Software Engineering best practices and working knowledge of C language preferred
• Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies
• Excellent verbal and written communication skills, strong problem-solving ability, and attention to detail
• Ability to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teams
• Ability to deal effectively with other employees and external business contacts while conveying a positive, service-oriented attitude.

Responsibilities

• 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.

Benefits

• Solventum offers many programs to help you live your best life – both physically and financially.
• To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees