[Hiring] Senior Engineering Program Director, Quality Strategy & Investigation Excellence @Medtronic

Role Description

Working closely with leaders across Quality, Engineering, Manufacturing, R&D, Clinical, Regulatory, Supply Chain, Customer Experience, and Digital organizations globally, you will establish and scale capabilities in root cause investigation, reliability engineering, advanced analytics, and quality intelligence. You will play a key role in driving investigation excellence, accelerating problem resolution, improving CAPA effectiveness, and enabling a more predictive and proactive quality organization.

This role requires a leader who can influence across organizational boundaries, develop technical capability, and guide the resolution of the most complex quality and reliability challenges facing the business. The role aligns with the organization's vision of connecting customer experience, field performance, analytics, reliability, and quality intelligence to improve business decisions and quality outcomes.

As Senior Director, Quality Strategy & Investigation Excellence, you will be accountable for building and sustaining capabilities across Reliability Engineering, Statistics & Analytics, and Root Cause Excellence. You will lead multiple strategic workstreams including:

• Investigation methodology
• Quality Reliability Engineering capability development
• Advanced analytical approaches
• Critical quality event support

You will partner across a global matrix to strengthen investigation effectiveness, improve organizational learning, and ensure quality decisions are increasingly data-driven, risk-based, and customer-focused. This role requires a leader who can balance strategy and execution, coach technical experts, align stakeholders, and build long-term organizational capability.

Responsibilities may include the following and other duties may be assigned:

• Establish and lead a centralized Investigation Excellence Engineering capability.
• Develop organizational strategy for Root Cause Analysis and advanced quality analytics.
• Lead the deployment and governance of advanced investigation methodologies, including: Shainin Red X, Lean Six-Sigma, and other structured problem-solving approaches.
• Own escalation support for critical investigations, major quality events, recalls, and CAPAs.
• Build communities of practice and technical career pathways for Quality Reliability Engineers.
• Develop and mentor technical experts in investigation disciplines.
• Establish standards for investigation quality, analytical rigor, and root cause determination.
• Partner with Quality, Engineering, Manufacturing, and R&D leaders to proactively identify emerging signals and improve product performance.
• Advance the organization's transition toward predictive, data-driven, and proactive quality management.
• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Qualifications

• Requires advanced management and leadership knowledge to lead cross-department project teams or manage across multiple functions.
• Typically has mastery within a specific technical or broad expertise across multiple related disciplines.
• Requires a Baccalaureate degree (or equivalent) and a minimum of 15 years of relevant experience with 10+ years of managerial experience, or an advanced degree with a minimum of 13 years of relevant experience and 10+ years of managerial experience.

Requirements

• Advanced degree (MS or PhD) in Engineering, Reliability Engineering, Statistics, Applied Mathematics, Data Science, Materials Science, or related discipline.
• Medical Device, Aerospace, Defense, Semiconductor, Automotive, Energy, or other high-reliability industry experience.
• Expertise in advanced root cause methodologies such as:
  • Shainin Red X
  • Fault Tree Analysis (FTA)
  • Apollo RCA
  • Event & Causal Factor Analysis
  • Physics of Failure
  • Reliability-Centered investigations
  • 6-Sigma
• Experience building or leading Reliability Engineering, Failure Analysis, Investigation Excellence, or Quality Intelligence organizations.
• Expertise in reliability methodologies including Weibull analysis, reliability growth, accelerated life testing, and reliability modeling.
• Expertise in advanced statistical methods including DOE, regression modeling, predictive analytics, Bayesian methods, and complex data interpretation.
• Experience deploying enterprise-wide technical training and certification programs.
• Experience developing communities of practice and technical career frameworks.
• Formal certifications in Reliability Engineering, Six Sigma, Shainin Red X, Quality Engineering, Statistics, or related disciplines.

Benefits

• 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.
• 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).