Principal Software Quality Assurance Engineer (Remote - United States)

• 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.

Do you have experience in Quality assurance within IT?, Do you have a Master's degree?, * 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, * 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, * 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.

3.43.4 out of 5 stars San Antonio, TX Remote $124,000 - $170,500 a year - Full-time, Pulled from the full job description

• Health insurance
• Retirement plan
• Vision insurance
• Health savings account
• Dental insurance
• Flexible spending account
• Relocation assistance, Applicable to US Applicants Only:The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status, 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, Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County. Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.