Principal Compliance Audit Specialist - Software and Security

We anticipate the application window for this opening will close on - 7 Jul 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 audit focus will be primarily medical device software, product security, 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 and knowledge working with regulated medical devices and cybersecurity requirements.

• 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 SaMD, SiMD, and product security designed to increase auditor awareness and knowledge of requirements.

• Remain informed on Regulatory requirements for Software and Product Security to identify gaps in medical device software.

• Provide detailed functional knowledge and maintain insight to 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 product security.

• Identify opportunities for product security enhancement.

• Possess understanding of Software Bill of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring.

• Possess an understanding of scoring methodologies for security threats like the common vulnerability scoring (CVSS) and apply appropriately.

• Document and communicate recommended security controls and deficiencies.

• Provide detailed functional knowledge and maintain insight to current industry best practices and how they can be applied to Medtronic.

• Contribute to company standards and policies related to product security risks.

• Enable strong partnerships across the organization to drive best-in-class product security mechanisms.

• 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%

Onsite

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

• Security Certifications (i.e., CISSP, CEH, CISA, CISM, Security+, GSEC, OSCP, etc.)

• Firsthand experience assessing the embedded security of regulated or safety critical devices.

• Experience in Quality/Compliance and/or Audit with medical device requirements (e.g., MDSAP, EU MDR, ISO 13485).

• Experience with cybersecurity requirements.

• TUV; EU MDR / MDCG.

• IMDRF’s Principles and Practices for Medical Device Cybersecurity.

• ENISA – EU Cybersecurity Act.

• European Commission’s Guidance on Cybersecurity of Medical Devices (MDCG).

• United States FDA Pre-Market and Post-Market Guidance.

• TIR 57 and TIR 97.

• ISO 80001-2 series and 14971.

• 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 security development process and product development process.

• Experience in leading small teams.

• Knowledge in risk management and assessment methodologies, security 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.

• A solid familiarity of threat modeling, vulnerability scanning tools, and common attack routes is essential.

• Medical device engineering experience.

• Strong technical and troubleshooting skills.

• Strong capability to research and evaluate emerging technologies

• Preference is given to those with relevant product security or engineering experience.

• Strong in interpersonal communication and 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

• Strong communication and collaboration skills.

• Solid writing and presentation skills.

• Interest in novel applications of technology.

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 - $170,400.00

This 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.