Principal Software Quality Assurance Engineer (Remote - United States)
WFA Digital Insight
The demand for skilled software quality assurance engineers in the healthcare industry is on the rise, with a 25% increase in job openings over the past year. Solventum, a newly formed company with a legacy of innovation, is at the forefront of this trend. As a Principal Software Quality Assurance Engineer, you will have the opportunity to work on cutting-edge medical device software, ensuring the highest standards of quality and safety. With a strong foundation in computer science and software engineering, you will be well-equipped to succeed in this role. Before applying, candidates should be aware of the importance of regulatory compliance, software testing, and risk management in the healthcare industry.
Job Description
About the Role
As a Principal Software Quality Assurance Engineer at Solventum, you will play a critical role in ensuring the quality and safety of medical device software. You will be responsible for leading software assurance activities throughout the software life cycle, from creation to release. Your expertise will be essential in ensuring compliance with regulatory requirements and industry standards.The software quality assurance team at Solventum is a dynamic and collaborative group, working closely with cross-functional teams to deliver innovative solutions. As a Principal Software Quality Assurance Engineer, you will be an integral part of this team, providing guidance and support to ensure the highest standards of quality and safety.
Solventum is committed to fostering a culture of innovation, empathy, and clinical intelligence. As a member of the team, you will be expected to embody these values, working closely with stakeholders to deliver solutions that improve patient outcomes and healthcare professionals' performance.
What You Will Do
- Lead software assurance activities throughout the medical device software life cycle
- Create software quality assurance plans, determine software safety classification, and ensure software test readiness
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards
- Conduct physical and functional configuration audits, review and approve software requirements, and provide insight to management regarding software project status and software quality metrics
- Ensure traceability upwards to system level requirements and safety/security risk controls, as well as downwards to software design, implementation, and testing
- Act as a quality champion in software product development and testing teams
- Support other software-related processes, such as CAPA process and cybersecurity risk management
- Perform gap assessments and elevate major problems with device software to management
- Collaborate with the brightest minds in healthcare to deliver innovative solutions
What We Are Looking For
- Master's degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science
- Five or more years of experience in software quality assurance in the medical device, aerospace, or automotive industry
- Strong foundation in software quality assurance principles, methodologies, and tools
- Experience with regulatory requirements and industry standards, such as FDA, ISO, and IEC
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
- Strong analytical and problem-solving skills, with the ability to identify and mitigate risks
- Experience with software development life cycles, including agile methodologies
- Proficiency in Excel and other software quality assurance tools
Nice to Have
- Experience with medical device software development and testing
- Knowledge of cybersecurity risk management and software quality assurance
- Familiarity with cloud-based technologies and DevOps practices
- Certification in software quality assurance or a related field
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work on cutting-edge medical device software
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Flexible remote work arrangements
- Access to the latest software quality assurance tools and technologies
- Recognition and reward for outstanding performance
- Comprehensive health and wellness programs
- Generous paid time off and holiday schedule
How to Stand Out
- Tip: Make sure to highlight your experience with software quality assurance principles, methodologies, and tools in your application.
- Be prepared to discuss your approach to ensuring compliance with regulatory requirements and industry standards.
- Showcase your analytical and problem-solving skills by providing examples of how you have identified and mitigated risks in previous roles.
- Familiarize yourself with Solventum's products and services, and be prepared to discuss how your skills and experience align with the company's goals and mission.
- Consider creating a portfolio that demonstrates your experience with software quality assurance, including examples of your work and any relevant certifications or training.
- When negotiating salary, be sure to research the market rate for Principal Software Quality Assurance Engineers in the healthcare industry and be prepared to make a strong case for your worth.
- Red flag: Be cautious of companies that do not prioritize software quality assurance or do not provide adequate resources and support for quality assurance activities.
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