Software and Cybersecurity Design Verification Manager

Solventum•San Antonio, TX

2d•Hybrid

About The Position

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 as a protected veteran. Job Description: Manager, Software Design Verification – Medical Device Software & Cybersecurity (Solventum) 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 Manager, Design Verification – Medical Device Software & Cybersecurity 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 verification and cybersecurity efforts for our medical device portfolio. This involves working with software quality assurance and design teams to ensure medical device software meets high standards of safety, reliability, regulatory compliance, and cybersecurity Overseeing planning and execution of verification and validation activities, including test strategy development, execution, and documentation. Ensuring regulatory compliance via adherence to the company’s Quality systems policies, procedures, FDA and other worldwide regulatory agency guidelines and international standards such as ISO 13485, IEC 62304, and ISO 14971 throughout the software development lifecycle. Implementing secure coding practices, conducting threat modeling and vulnerability assessments, and maintaining compliance with cybersecurity requirements for connected medical devices. Reviewing and preparing clear, audit-ready documentation for regulatory submissions and facilitating effective communication across technical and non-technical stakeholders Manage and mentor technical teams, drive continuous improvement initiatives using methodologies like Six Sigma or DOE, and optimize workflows for efficiency and quality. Supporting the supplier audit process, CAPA process, and other quality related process regarding cybersecurity risk management and software quality assurance.

Requirements

Bachelor’s degree in Computer Science, Cybersecurity or related degree, or equivalent and (7) seven years of experience in software development or verification in a private, public, government, or military environment
AND (3 ) three years leadership experience in a private, public, government, or military environment
AND Experience in medical device software or other regulated industry with equivalent software safety and security standards in a private, public, government, or military environment
AND Proven experience in cybersecurity practices for software systems.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

Experience in crafting design Verification strategies, processes, resources and testing activities in support of new product development and sustaining project requirements.
Strong test management skills including test and resource planning and project management.
Excellent verbal and written communication skills, strong problem-solving ability, and attention to detail and ability to work in and lead cross-functional teams.
Demonstrated ability to present technical information effectively to different levels within the organization, including summaries for management and non-technical associates.
Experience condensing complex requirements into specific and measurable test objectives
Ability to work in a fast-paced environment, to manage and to prioritize multiple competing tasks for testing
Certifications in cybersecurity (e.g., CISSP) or quality management (e.g., Six Sigma).
5 years relevant design control, risk management, design transfer and Quality Management System experience within an FDA regulated industry required.
Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies
Familiarity with tools such as Azure DevOps, JIRA, or similar platforms.
Experience with risk management and statistical process control.
Experience leading and documenting threat modelling and vulnerability assessments, and using associated frameworks
Experience conducting penetration testing, malformed input testing / fuzz testing, static analysis security testing (SAST), and creating appropriate documentation
Experience with other forms of security testing and activities, such as software composition analysis (SCA), SBOM generation and monitoring, etc.

Responsibilities

Leading software verification and cybersecurity efforts for our medical device portfolio. This involves working with software quality assurance and design teams to ensure medical device software meets high standards of safety, reliability, regulatory compliance, and cybersecurity
Overseeing planning and execution of verification and validation activities, including test strategy development, execution, and documentation.
Ensuring regulatory compliance via adherence to the company’s Quality systems policies, procedures, FDA and other worldwide regulatory agency guidelines and international standards such as ISO 13485, IEC 62304, and ISO 14971 throughout the software development lifecycle.
Implementing secure coding practices, conducting threat modeling and vulnerability assessments, and maintaining compliance with cybersecurity requirements for connected medical devices.
Reviewing and preparing clear, audit-ready documentation for regulatory submissions and facilitating effective communication across technical and non-technical stakeholders
Manage and mentor technical teams, drive continuous improvement initiatives using methodologies like Six Sigma or DOE, and optimize workflows for efficiency and quality.
Supporting the supplier audit process, CAPA process, and other quality related process 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, etc.

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