Principal Software and Security Compliance Audit Specialist

We anticipate the application window for this opening will close on - 7 Oct 2025

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 Principal Compliance Audit Specialist – Software and Product Cybersecurity position focuses on auditing regulated 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%

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

Must Have: Minimum 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

Nice To Have

• 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:

• Eu Ai Act

• 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
• 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.

• Independent Self-Starter

• Solid writing and presentation skills
• Interest in novel applications of technology
• 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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$113,600.00 - $170,400.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.