Principal Software and Security Compliance Audit Specialist

Medtronic•Minneapolis, MN

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. The audit focus will be primarily medical device software, product cybersecurity, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned. Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements. Remain informed on Regulatory requirements for Software and Product Cybersecurity to identify gaps in medical device software. Manage and oversee internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents. Coordinate and/or complete internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities. Interpret and implement applicable regulations as they apply to products, processes, practices, and procedures. May counsel stakeholders about these requirements as necessary. Ensure compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns. Analyze audit data and present findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions. Own development of training and awareness programs for Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and product cybersecurity designed to increase auditor awareness and knowledge of requirements. Provide detailed functional medical device software and product security knowledge and maintain insight into current industry best practices and how they can be applied to Medtronic. Explore new tools and techniques to recommend for other team members to audit regulated medical device software and product cybersecurity. Identify opportunities for regulated medical device software and product security enhancement. Possess understanding of Software Bill of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring. Possess an understanding of non-probabilistic scoring methodologies for security threats like common vulnerability scoring system (CVSS) and apply appropriately. Document and communicate recommended state-of-the-art regulated medical device software and product cybersecurity controls and deficiencies. Contribute to company standards and policies related to regulated medical device software and product cybersecurity risks. Enable strong partnerships across the organization to drive best-in-class regulated medical device software and product cybersecurity development. Analyze complex issues and significantly improve, change, or adapt existing methods. Show creativity and innovation in all aspects of your responsibilities. Expected travel: 20-25%

Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor's degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+ years of work experience in Quality or regulated industry OR PhD with 3+ years of work experience in Quality or regulated industry

Nice To Haves

Preference is given to those with relevant software development or product cybersecurity engineering experience or background.
Experience in Quality/Compliance and/or Audit with medical device requirements (e.g., MDSAP, EU MDR, ISO 13485)
Experience with regulated medical device software requirements: IEC 62304:2006 + AMD1:2015 - Medical device software – Software life cycle processes IEC 82304-1:2016 - Health software – Part 1: General requirements for product safety United States FDA Device Software Functions related Guidance’s United States FDA Interoperability related Guidance’s United States FDA AI-Enabled Device Software Function Guidance European Commission’s Guidance’s on Medical Device Software (MDCG 2019-11, MDCG 2023-4, MDCG 2025-4) IMDRF’s Software as a Medical Device (SaMD) Guidance’s ISO 14971:2019 EU AI Act
Experience with regulated product cybersecurity requirements: IEC 81001-5-1:2021 - Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle SW96:2023 – Standard for Medical Device Security – Security Risk Management for Device Manufacturers United States FDA Pre-Market and Post-Market Product Cybersecurity Guidance’s European Commission’s Guidance on Cybersecurity of Medical Devices (MDCG 2019-16) IMDRF’s Principles and Practices for Medical Device Cybersecurity Guidance’s ENISA – EU Cybersecurity Act ISO 80001-2 series and ISO 14971
Security Certifications (i.e., CISSP, CEH, CISA, CISM, Security+, GSEC, OSCP, etc.)
Firsthand experience assessing medical device software and product cybersecurity of regulated or safety critical devices.
Experience auditing Quality Systems to global requirements
Quality System Lead Auditor certified
Prior FDA or NB auditor experience
Experience performing hardware and software penetration testing
Understanding of the software and product cybersecurity development lifecycle process and product development process
Experience in leading small teams
Knowledge in risk management and assessment methodologies, product cybersecurity frameworks and relevant global regulations
Strong capability to research and evaluate emerging technologies
A solid familiarity of threat modeling, vulnerability scanning tools, and common attack routes is essential.
Demonstrated ability to be flexible and take a proactive approach to managing change
Experience working in a regulated environment and/or a formal quality system
Occasional after-hours availability to accommodate different regional and global partners.
Medical device engineering experience
Strong technical and troubleshooting skills.
Strong interpersonal communication and ability to demonstrate a collaborative work style.
Comfortable working in an ambiguous environment.
Innovative thinker: ability to think outside of the current norms and processes
Independent self-starter
Solid writing and presentation skills
Interest in novel applications of technology

Responsibilities

Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements.
Remain informed on Regulatory requirements for Software and Product Cybersecurity to identify gaps in medical device software.
Manage and oversee internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
Coordinate and/or complete internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities.
Interpret and implement applicable regulations as they apply to products, processes, practices, and procedures.
May counsel stakeholders about these requirements as necessary.
Ensure compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
Analyze audit data and present findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
Own development of training and awareness programs for Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and product cybersecurity designed to increase auditor awareness and knowledge of requirements.
Provide detailed functional medical device software and product security knowledge and maintain insight into current industry best practices and how they can be applied to Medtronic.
Explore new tools and techniques to recommend for other team members to audit regulated medical device software and product cybersecurity.
Identify opportunities for regulated medical device software and product security enhancement.
Possess understanding of Software Bill of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring.
Possess an understanding of non-probabilistic scoring methodologies for security threats like common vulnerability scoring system (CVSS) and apply appropriately.
Document and communicate recommended state-of-the-art regulated medical device software and product cybersecurity controls and deficiencies.
Contribute to company standards and policies related to regulated medical device software and product cybersecurity risks.
Enable strong partnerships across the organization to drive best-in-class regulated medical device software and product cybersecurity development.
Analyze complex issues and significantly improve, change, or adapt existing methods.
Show creativity and innovation in all aspects of your responsibilities.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values.
We recognize their contributions.
They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).