Engineering Program Manager/QCTM - ENT - Jacksonville, FL (Onsite)

XOM Medtronic Xomed, LLC; Florida; On-site; USD 142,000 - 214,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) with employer match

Medtronic Incentive Plan (MIP)

Job summary

Medtronic plc in Jacksonville, Florida is seeking an Engineering Program Manager to serve as the Quality Core Team Member on cross-functional NPD programs. This onsite role drives quality, reliability, compliance, and risk management throughout the product lifecycle from concept through post-market transition.

You will partner with engineering, manufacturing, supplier quality, regulatory, and business stakeholders to define and sustain product quality requirements, design controls, and lifecycle

Qualifications

• Bachelor's degree with minimum 5 years of technical experience in an engineering, quality, technical or program management environment.
• Experience leading cross-functional product development or quality programs.
• Experience with quality systems, design controls and product lifecycle management processes.
• Experience supporting compliance with regulated industry requirements and standards.

Responsibilities

• Lead quality and reliability strategy, plans, metrics, and risk management activities for assigned new product development programs.
• Manage execution across extended quality functions, including design quality, software quality, supplier quality and manufacturing quality and reliability engineering teams.
• Represent the Voice of Quality on cross-functional core teams and serve as the final quality authority for assigned projects.
• Drive DRM, DfR, FTQ and defect prevention initiatives throughout product development.
• Identify quality and reliability risks, implement risk reduction strategies and lead root cause investigations and corrective and preventive actions.
• Partner with suppliers and manufacturing sites to evaluate quality risks, support sourcing decisions and ensure readiness for product launch and lifecycle management.
• Lead compliance planning, assessments, audit support activities and adherence to quality system and regulatory requirements.
• Support key development deliverables including Design History Files (DHF), Device Master Records (DMR), Production Part Approval Process (PPAP), regulatory submissions, software lifecycle documentation and product transfer activities.

Skills

Quality management

Risk management

Cross-functional collaboration

Regulatory compliance

Project management

Design for Reliability

Education

Bachelor's degree in engineering/quality

Master's degree in engineering/related field

Job description

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

This Engineering Program Manager role supports New Product Development (NPD) programs as the Quality Core Team Member (QCTM), serving as the Voice of Quality across design quality, reliability, supplier quality, manufacturing quality, quality systems, software quality, and post-market quality functions. The role is responsible for driving quality and reliability strategy throughout the product lifecycle, influencing product development decisions, and ensuring compliance with applicable quality and regulatory requirements. This position is based in Jacksonville, Florida and follows an onsite work model. Travel is expected to be less than 10% and may include visits to suppliers, manufacturing sites, or project-related meetings.

As an Engineering Program Manager, you will serve as the Quality Core Team Member (QCTM) on cross-functional new product development programs, providing strategic leadership for quality, reliability, compliance, and risk management activities. You will partner with engineering, manufacturing, supplier quality, regulatory and business stakeholders to ensure product quality requirements are defined, implemented, and sustained from concept through commercialization and post-market transition.

Primary Responsibilities

• Lead quality and reliability strategy, plans, metrics, and risk management activities for assigned new product development programs.
• Manage execution across extended quality functions, including design quality, software quality, supplier quality and manufacturing quality and reliability engineering teams.
• Represent the Voice of Quality on cross-functional core teams and serve as the final quality authority for assigned projects.
• Drive Design Reliability and Manufacturability (DRM), Design for Reliability (DfR), First Time Quality (FTQ) and defect prevention initiatives throughout product development.
• Identify quality and reliability risks, implement risk reduction strategies and lead root cause investigations and corrective and preventive actions.
• Partner with suppliers and manufacturing sites to evaluate quality risks, support sourcing decisions and ensure readiness for product launch and lifecycle management.
• Lead compliance planning, assessments, audit support activities and adherence to quality system and regulatory requirements.
• Support key development deliverables including Design History Files (DHF), Device Master Records (DMR), Production Part Approval Process (PPAP), regulatory submissions, software lifecycle documentation and product transfer activities.

Required Qualifications

• Bachelor's degree with minimum 5 years of technical experience in an engineering, quality, technical or program management environment OR Master's degree with minimum 3 years of technical experience in an engineering, quality, technical or program management environment.
• Experience leading cross-functional product development or quality programs.
• Experience applying risk management, quality, and reliability methodologies in regulated product development environments.
• Experience with quality systems, design controls and product lifecycle management processes.
• Experience supporting compliance with regulated industry requirements and standards.
• 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.

Preferred Qualifications

• Project Management Professional (PMP) certification.
• Design Reliability and Manufacturability (DRM) certification or equivalent experience.
• First Time Quality (FTQ) certification.
• Experience with medical device product development and software development lifecycle processes.
• Knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 14971 and IEC 62304 requirements.

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):$142,400.00 - $213,600.00

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).

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.

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.

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.