Engineering Director

Quality Engineering Director

Medtronic, a global leader in medical technology, services, and solutions, is seeking an accomplished Quality Engineering Director to lead the Surgical Operating Unit's New Product Development Risk Management and Reliability Quality team. This role is responsible for providing strategic and operational leadership for quality engineering activities that support the development of safe, effective, and compliant medical devices throughout the product lifecycle. The Quality Engineering Director will lead a team of quality engineering professionals focused on new product development and will play a critical role in ensuring patient safety and product quality. This position requires a strong people leader who can mentor, coach, and develop talent while driving execution against performance expectations and program commitments. The ideal candidate will bring deep expertise in quality engineering within the medical device industry, including reliability science, risk management, design controls, and regulatory compliance. This role can sit at one of our core Surgical sites (Mounds View, MN, Lafayette, CO, North Have, CT or Boston, Massachusetts).

Key Responsibilities

Responsibilities may include the following:

• Lead and develop the Surgical Operating Unit's New Product Development Risk Management and Reliability Quality team, including mentoring, coaching, and managing performance to meet organizational and program objectives.
• Provide strategic leadership to prioritize departmental initiatives and align team goals with broader business and functional objectives.
• Establish performance goals and targets, conduct performance reviews, and lead regular one-on-one discussions to support employee development and performance management.
• Direct and guide employees in the design and development of medical device products and systems.
• Develop, implement, and continuously improve objectives, policies, processes, and standards to support business strategy and drive functional excellence through best practices.
• Select, hire, and develop talent, ensuring the right capabilities are aligned to the right programs and roles for efficient and effective team performance.
• Collaborate effectively across functions and businesses, balancing competing priorities and influencing stakeholders to achieve shared outcomes.
• Manage the departmental budget and ensure effective allocation of resources.
• Lead the team in creating and maintaining the risk management file, including risk management plans and reports, and conducting regular risk reviews.
• Ensure quality deliverables for new product development activities are executed in compliance with applicable regulatory requirements and internal quality standards.
• Serve as a key quality leader in the medical device development process, with a strong focus on patient safety across the full product lifecycle.

Required Qualifications

Must Have: Minimum Requirements

• Bachelor of Engineering or technical degree required
• Minimum of 10 years of relevant experience which includes experience in Quality New Product Development or advanced degree with a minimum of 8 years of experience
• 7+ years of managerial experience to include demonstrated people leadership experience

Preferred Qualifications

Nice to Have Experience:

• Strong background in Quality New Product Development
• Expertise in reliability science, risk management, design controls, and regulatory compliance
• Ability to work effectively in cross-functional teams and influence across a matrixed organization
• Strong initiative, curiosity, learning agility, and problem-solving skills
• Expertise in quality management systems and statistical methods and analysis

Certifications:

• Certified Quality Engineer (CQE)
• Six Sigma Green Belt or equivalent certification
• AAMI design control certification

Industry Experience:

• Medical device industry experience
• Understanding of relevant regulatory requirements, including ISO 14971, ISO 13485, IEC 62304, and FDA Part 820

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):$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 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