Director of IT, PLM & QMS

Medtronic•Northridge, CA

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 The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers with greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease. For more information, visit us at www.medtronic.com and www.medtronicdiabetes.com. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. As part of our spin-off from our parent company Medtronic, we are building a standalone IT function to drive strategic growth and operational excellence. We are seeking a Director of IT for R&D (Innovation, ALM, PLM) and Quality Management to lead and manage IT operations. The Director of IT, PLM and QMS, is responsible for the reliable and secure operation of IT systems and services supporting our product innovation lifecycle quality business execution. This includes ownership of systems such as PTC Codebeamer, SmartSolve, Agile, PTC Windchill, Veeva and a variety of other applications and services that are critical to our pre and post market enablement.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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)