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

Medtronic•Jacksonville, FL

10d•Onsite

About The Position

The Engineering Program Manager supports New Product Development (NPD) programs as the Quality Core Team Member (QCTM) and serves as the Voice of Quality across design quality, reliability, supplier quality, manufacturing quality, quality systems, software quality, and post-market quality functions. The role provides strategic leadership for quality, reliability, compliance, and risk management throughout the product lifecycle, influencing development decisions and ensuring applicable quality and regulatory requirements are met. 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. It is based onsite in Jacksonville, Florida, with expected travel below 10%, potentially to suppliers, manufacturing sites, or 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 technical 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.
Health insurance.
Dental insurance.
Vision insurance.
Health Savings Account.
Healthcare Flexible Spending Account.
Life insurance.
Long-term disability leave.
Dependent daycare spending account.
Tuition assistance or reimbursement.
Simple Steps global well-being program.
Incentive plans, including eligibility for the Medtronic Incentive Plan (MIP) short-term incentive.
401(k) plan with 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.
Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.