Premarket Quality Engineering Director (ICT), Santa Ana, CA

We anticipate the application window for this opening will close on - 31 Aug 2026Careers 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 LifeCareers that Change LivesIn this role, you will lead cross-functional program teams to deliver innovative product In this role, you will lead the Premarket Quality Engineering function and partner with cross-functional program teams to deliver innovative products that improve patient outcomes while ensuring compliance with all applicable regulatory requirements, quality standards, and business objectives. You will be responsible for driving quality excellence throughout the product development lifecycle, enabling successful and timely product launches while maintaining the highest standards of patient safety, product quality, and regulatory compliance.As the leader of the Design Assurance Engineering organization, you will build, develop, and sustain a high-performing team with the capabilities, expertise, and capacity required to support current and future product development programs. You will provide strategic and operational leadership for design control activities, risk management, design verification, test method development, and test method validation, ensuring quality is proactively integrated into all phases of new product development.You will collaborate closely with leaders and stakeholders across Research & Development, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, Program Management, and Operations to drive effective decision-making, manage quality risks, and foster a culture of partnership, accountability, and continuous improvement. Through strong leadership and influence, you will help create an environment where cross-functional teams work together seamlessly to achieve program milestones and business objectives.In addition, you will partner with site and functional leadership teams to develop and execute strategic initiatives that strengthen organizational capabilities, improve development processes, advance operational excellence, and position the business for future growth. This role requires a forward-looking business mindset, balancing near-term program execution with long-term organizational development, talent strategy, and continuous improvement opportunities that enhance product development effectiveness and quality outcomes.The successful candidate will be a strategic people leader with a passion for developing talent, building strong teams, driving collaboration, and delivering innovative products to market that improve the lives of patients around the world. This position is onsite, based in Santa Ana, CA.Program Leadership & ExecutionLeads Premarket Quality Engineering teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies.Defines and executes operational aspects of product development programs including: schedule, project risk identification and mitigation plans, issue management, program management owned deliverable, budget and resource forecastingMonitors program progress and status through defined program objectives, KPIs, schedule progress, risk burndown, and effective issue mitigation and resolution strategiesDevelops mechanisms for tracking program performance, ensuring accountability, and enabling proactive interventionStakeholder EngagementDrive strategic and executional alignment across R&D, Quality, Regulatory, Operations, and other partner functions within program teamCreates clear and concise program updates, risks, and recommendations for use in communication with leadershipProgram Governance & StrategyDemonstrates strategic thinking in establishing and managing program plans, requirements, and execution strategies that are aligned to the business prioritiesEnsure compliance with design controls requirements, quality systems, and regulatory requirements.Acts as subject matter expert to the team in the Product Development Process (PDP)Talent LeadershipLeads, develops, and mentors a high-performing global organization of quality engineers, managers, and technical leaders.Fosters a culture of inclusion, accountability, innovation, collaboration, and continuous improvement.Builds organizational capability in systems engineering, software quality, advanced quality methodologies, and risk management.Develops future leaders through coaching, succession planning, and talent development initiatives.Responsibilities may include the following and other duties may be assigned.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.Must Have: Minimum Requirements- To be considered for this role, please ensure the minimum requirements are evident in your applicant profile:Bachelors degree required10 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 Have:Experience supporting Class II and/or Class III medical devicesDemonstrated expertise in design controls, risk management, and product development qualityAbout Medtronic:Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.Physical Job Requirements: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. (ADA-United States of America).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. Learn more about our benefits here.This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.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).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 RequirementsThe 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 AlertWe 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 View email address on click.appcast.io. ‌Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$198,400.00 - $297,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.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, 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 plansIt 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.SummaryLocation: Santa Ana, California, United States of AmericaType: Full time