Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. 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 as a protected veteran.Job Description:Job Title: Senior Software Quality Engineer (Solventum)3M Health Care is now SolventumAt 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 RoleAs a(n) Senior 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:Leads software quality assurance activities throughout medical device software life cycle, including creating software quality assurance, cyber risk assessment plans and reports, software bill of materials (SBOMs), designing secure architectures, performing and/or supervising security testing, monitoring vulnerabilities, and more. Implements standard operating procedures for medical device software engineering, takes an active role in continuous improvement of the medical device software engineering process, including authoring, reviewing, and approving procedures, work instructions and templates.Determines software safety classification, software test readiness, software release readiness, cyber risk profile. Is expected to be an active member of the software team during the whole software life cycle, with responsibility for reviewing and approving software requirements, software design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics. Ensures compliance with applicable regulatory requirements and industry standards. Immediately elevates to management any major problem with device software that could affect safety, data security, customer usability or system adherence to process requirementsActs as a security champion in software product development teams, analyzing system designs for vulnerabilities determining cyber risk profile, estimating security risks, defining security controls, interacting with engineers, design assurance, quality and regulatory to ensure compliance with cybersecurity regulations and ATO readiness. Interacts with other security teams to monitor and respond to cyber signals.Supports the supplier audit process, CAPA process, and other quality related process regarding cybersecurity risk management and software quality assurance.Your Skills and ExpertiseTo set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:To set you up for success in this ro e from day one, 3M requires (at a minimum) the following qualifications:Bachelor's Degree or higher AND 5 years of experience in software safety and security standardsORHigh School Diploma/GED AND 9 years of software safety and security standards5 years of experience in medical device software or other regulated industryExperience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologiesAdditional qualifications that could help you succeed even further in this role include:Master's degree in Computer Science, Cybersecurity and 3 years of experience in medical device softwareWorking 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, amongst others.Experience leading and documenting threat modelling and vulnerability assessments, and using frameworks such as the STRIDE methodology and CVSS vulnerability scoringExperience conducting penetration testing, malformed input testing / fuzz testing, static analysis security testing (SAST), and creating appropriate documentationExperience with other forms of security testing and activities, such as software composition analysis (SCA), SBOM generation and monitoring, and moreWorking knowledge of C language and cryptography preferredExcellent verbal and written communication skills, strong problem-solving ability, and attention to detailAbility to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teamsAbility to deal effectively with all employees and...Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity