Engineering Program Manager/QCTM - ENT - Jacksonville, FL (Onsite)
About The Position
The Engineering Program Manager serves as the Quality Core Team Member (QCTM) on cross-functional new product development programs, providing strategic leadership for quality, reliability, compliance, and risk management. The role represents the Voice of Quality across design quality, reliability, supplier quality, manufacturing quality, quality systems, software quality, and post-market quality functions. It drives quality and reliability strategy throughout the product lifecycle, influences product development decisions, and ensures compliance with applicable quality and regulatory requirements. Based onsite in Jacksonville, Florida, the position partners with engineering, manufacturing, supplier quality, regulatory, and business stakeholders to define, implement, and sustain product quality requirements from concept through commercialization and post-market transition. Travel is expected to be less than 10% and may include supplier or manufacturing site visits and project-related meetings.
Requirements
- Bachelor's degree and at least 5 years of technical experience in an engineering, quality, technical, or program management environment, or a Master's degree and at least 3 years of such experience.
- 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 the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- 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.
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, 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 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.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
- Health Savings Account and Healthcare Flexible Spending Account for eligible regular employees working 20 or more hours per week.
- Life insurance and long-term disability leave for eligible regular employees working 20 or more hours per week.
- Dependent daycare spending account for eligible regular employees working 20 or more hours per week.
- Tuition assistance/reimbursement for eligible regular employees working 20 or more hours per week.
- Simple Steps global well-being program for eligible regular employees working 20 or more hours per week.
- Incentive plans for all regular employees.
- 401(k) plan with employer contribution and match for all regular employees.
- Short-term disability and paid time off for all regular employees.
- Paid holidays for all regular employees.
- Employee Stock Purchase Plan for all regular employees.
- Employee Assistance Program for all regular employees.
- Non-qualified Retirement Plan Supplement, subject to IRS earning minimums, for all regular employees.
- Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
