Director Statistical Programming Jobs in Irvine, CA

We anticipate the application window for this opening will close on - 29 Aug 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
Across our global Neuroscience organization, we advance care for some of medicine's most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.
Our Neurovascular operating unit advances treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. With devices designed for revascularization, embolization, and precise intervention, we support clinicians in delivering timely, effective care for complex neurovascular conditions.
Check us out on LinkedIn: Medtronic Neurovascular
As a Neurovascular Sr. Design Quality Engineer, you will have responsibility for directly contributing to the design of life-saving Neurovascular devices.
You will integrate into every aspect of new product development, processes, and planning to deliver world-class and high-quality treatments. Problems and issues faced are difficult, complex, often undefined, and require detailed information gathering, analysis, and investigation. Critical thinking and curiosity are vital to finding timely solutions to ensure optimal performance and safety.
As a voice of the patient, Design Quality Engineers at Medtronic go well beyond meeting internal and external requirements; they actively integrate into the design team and personally contribute to the technical design and performance.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Ability to travel up to: <25% (domestic and international)
Responsibilities may include the following and other duties may be assigned.

• Direct contribution and hands-on collaboration with R&D and Process Development to influence and contribute to the design of cutting-edge medical devices.
• Flexes with other Quality Engineers to provide targeted support depending on project phase.
• Mentor other engineers and be mentored.
• Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Apply Design for Manufacturability and Reliability principles.
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Identifies and manages risk throughout the product lifecycle with the application of risk management tools.
• Completes risk analysis studies of new designs and processes.
• Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
• As necessary, proposes changes in design or formulation to improve system and/or process reliability.
• May serve as Core Reliability and Quality Engineer for R&D Programs
• Oversees Validation & Verification activities.

Must Have (Minimum Requirements)

• Bachelor's degree (Engineering or Science) required
• Minimum of 4 years of experience in Engineering and/or Quality OR advanced degree with a minimum of 2 years of experience.

Nice to Have (Preferred Qualifications)

• Experience with Vascular/Neurovascular devices
• Background in product realization and Design Engineering / Quality
• Advanced Statistics - 2+ years working with Minitab, DOE, Capability analysis, stability analysis, graphical analysis, etc.
• Risk Management and Analysis
• Process Improvement Methodologies, such as Six Sigma, DOE, LEAN
• ISO standards, including ISO13485 Medical Device Directives (MDD)/Vigilance Reporting, EU MDD, EU MDR, FDA QSR
• Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• ASQ Certification

A preferred candidate has practical expertise in one (or more) of these key topics:

• DRM - Requirements Flow-down, Design Characterization, & Process Characterization
• Material Engineering / Testing - Metals
• Material Engineering/testing - Polymers

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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
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):$107,200.00 - $160,800.00
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 applies solely to candidates hired within the United States (local-market compensation and benefits will apply to 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, 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
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.