Sr. Engineering Program Director, Quality Strategy & Investigation Excellence

Medtronic; United States; Remote; USD 223,000 - 335,000; Full time

Job summary

Medtronic plc is seeking a Senior Director of Quality Strategy & Investigation Excellence to drive capabilities in reliability engineering, statistics, and root-cause investigation across global teams. You will shape investigation methodologies, lead complex problem-solving, and align stakeholders to data-driven quality decisions.

The role partners with Quality, Engineering, Manufacturing, and R&D to advance predictive quality management and organizational capability.

Qualifications

• Requires an advanced degree in Engineering, Reliability Engineering, Statistics, Applied Mathematics, Data Science, Materials Science, or related discipline.
• Experience leading Reliability Engineering, Failure Analysis, Investigation Excellence, or Quality Intelligence teams.
• Formal certifications in Reliability Engineering, Six Sigma, Shainin Red X, Quality Engineering, or Statistics are preferred.

Responsibilities

• Establish and lead centralized Investigation Excellence Engineering capability.
• Develop strategy for Root Cause Analysis and advanced quality analytics.
• Lead deployment of advanced investigation methodologies.
• Partner with Quality, Engineering, Manufacturing, and R&D leaders to identify signals and improve product performance.
• Mentor technical experts and establish standards for investigation quality and rigor.

Skills

Leadership

Quality Management

Root Cause Analysis

Data Analytics

Reliability Engineering

Shainin Red X

Six Sigma

Cross-Functional Collaboration

Quality Improvement

Education

Advanced degree in Engineering / related field

MS or PhD in Reliability Engineering / Statistics

Tools

Shainin Red X

Fault Tree Analysis (FTA)

DOE

Weibull Analysis

Job description

We anticipate the application window for this opening will close on - 9 Nov 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

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, and 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.

PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility, managing program/team performance, communicating project and operational developments, planning, prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.

DIFFERENTIATING FACTORS

Autonomy: Manages multiple major, strategic programs and initiatives across the organization that require strong influence outside of immediate program stakeholders. Is accountable for overall program portfolio success. Assesses business strategy and recommends new programs or program changes.

Organizational Impact: Establishes program portfolio objectives, timelines, milestones, and budgets for multiple interconnected programs. Identifies business need and establishes new policies and procedures that affect program management. Has budget accountability for one or more strategic programs. Program decisions are made independently with strategic or costly decisions recommended to higher level management.

Innovation and Complexity: Problems and issues faced are complex, undefined and impact multiple businesses, functions or programs, where information is typically difficult to obtain and extensive investigation to understand the root cause of problems is required. Responsible for changing or improving upon entire processes or systems using significant conceptualizing, reasoning and interpretation skills.

Communication and Influence: Communicates and conducts briefings with senior or executive leadership regarding new strategic program proposals and critical program outcomes. Serves as principal spokesperson for multiple programs, interacting with leaders and executives on highly significant matters . Influences across functions, businesses and with external stakeholders to gain support of strategic programs where there are competing objectives and perspectives .

Leadership and Talent Management: Leads a matrixed large unit that typically includes multiple teams led by Program Managers and/or vendors. Approves tasks and schedule necessary for successful program execution. Not directly responsible for hire or fire decisions and people management.

Required Knowledge and Experience: 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 for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 15 years of relevant experience with 10+ years of managerial experience, or advanced degree with a minimum 13 years of relevant experience and 10+ years of managerial experience.

Preferred Knowledge and Experience:

• 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.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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):$223,200.00 - $334,800.00

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, andSimple 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), andCapital 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

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 findhere 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.