Posted:
12/2/2025, 8:13:51 AM
Location(s):
Los Angeles, California, United States ⋅ California, United States
Experience Level(s):
Expert or higher ⋅ Senior
Field(s):
IT & Security
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.
Responsibilities may include the following and other duties may be assigned.
Collaborate closely with business function leaders to establish and drive a process, data and technology roadmap across the R&D, Quality and Regulatory Systems value chain.
Champion digital transformation initiatives and global cloud system implementations across the pre and post market capabilities to enable Application/Product lifecycle management, Quality management, CAPA, Complaints handling.
Ensure regulatory readiness and support FDA audits by maintaining validated system states (ISO 13485, HIPAA, GDPR compliance) into all deployments and across all IT services.
Partner closely with our Director of IT, Manufacturing and Director of Business Systems to achieve system integrations across enterprise platforms, such as linking QMS/PLM with ERP (e.g., SAP), MES/LIMS, and laboratory systems for seamless data flow and end-to-end visibility.
Establish clear, measurement IT services with clear KPIs, balanced scorecards, and performance analytics to measure system health, user adoption, and ROI on technology investments, with a focus on risk-based prioritization.
Develop and lead a highly skilled and effective digital team to zipper the relationship between business experts and technology experts to ensure a tightly aligned IT portfolio and business priorities.
Required Knowledge and Experience:
Requires a Bachelors degree and minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience.
Preferred Qualifications:
15+ years in IT leadership within life sciences, with at least 5 years specifically in medical device or pharmaceutical regulated settings, including direct support for global operations across multiple time zones and cultures.
Demonstrated success leading multiple major system implementations or upgrades (e.g., QMS/PLM migrations) in ISO compliant, GxP-validated environments, with expertise in full SDLC (Software Development Life Cycle) using Agile/Scrum and Waterfall methodologies.
Hands-on experience with additional QMS/PLM platforms such as PTC Windchill, Veeva, Siemens Teamcenter (for ALM/requirements management) and other industry software products and providers.
In-depth knowledge of global regulations beyond core QMS, including GMP/GLP, ISO 27001 for information security, ISO 13485 for QMS software, 21 CFR Part 11 for electronic records/signatures, and awareness of cybersecurity frameworks like NIST or SOC 2.
Proven experience integrating DevOps practices, CI/CD pipelines (e.g., GitLab, Terraform), and Infrastructure as Code (IaC) into QMS/R&D deployments to accelerate delivery while ensuring traceability and compliance.
Proven hands-on technical leadership within a medical device company.
Exposure to advanced analytics/BI tools (e.g., Databricks, Power BI) or AI LLMs/Agentic for predictive quality risk assessment, CAPA optimization, or post-market surveillance trend analysis.
Certification in project management (e.g., PMP), IT service management (e.g., ITIL), or quality systems (e.g., ASQ CQE), plus Lean Six Sigma Green Belt for process optimization.
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.
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.
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
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.
Website: https://www.medtronic.com/
Headquarter Location: Mumbai, Maharashtra, India
Employee Count: 1001-5000
Year Founded: 1979
IPO Status: Private
Industries: Health Care ⋅ Manufacturing ⋅ Medical Device