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

• →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, 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.

• 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.

• 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.

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.

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.

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.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

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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.