Prin Software and Product Security Compliance Specialist (Remote)

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

CAREERS THAT CHANGE LIVES

In this exciting role as a Principal Software and Product Security Compliance/Audit Specialist you will have responsibility to plan, lead, conduct and report on internal audits of Medtronic facilities worldwide to determine the state of compliance to appropriate regulations and standards, corporate policies, and expectations. Additionally responsible for training and education of internal audit organization to SaMD, SiMD, and product security requirements. 

A Day in the Life

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. 

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.  Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.  We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications if we hope to have long-term sustainable impact.

As a Prin Software and Product Security Compliance Specialist:

• Must have experience and knowledge working with regulated medical devices and cybersecurity requirements.
• Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
• Coordinates and/or completes internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities.
• Interprets and implements applicable regulations as they apply to products, processes, practices, and procedures.
• May counsel stakeholders about these requirements as necessary.
• Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
• Analyzes audit data and presents 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.
• Analyzes complex issues and significantly improves, changes, or adapts existing methods.
• Show creativity and innovation in all aspects of your responsibilities
• Expected travel: 20-25%
• Role may be remote, hybrid, or in office.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

QUALIFICATIONS:

• Bachelor's degree

YEARS OF EXPERIENCE:

• 4+ years of cybersecurity and/or secure software engineering experience in quality or regulatory industry with a Bachelor's Degree
• 2+ years of cybersecurity and/or secure software engineering experience in quality or regulatory industry with an Advanced Degree

SPECIALIZED SKILLS OR EXPERIENCE: 

• Experience in Product Security
• Excellent written and verbal communication skills including demonstrated influence of stakeholders across an organization

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):$113,000-$170,000

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).

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 90,000+ 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.

At Medtronic, most positions are posted on our career site for 3-7 days.