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

Description

Applications for this role close on 14 Nov 2026.

The role sits within new product development at a global healthcare technology company with about 95,000 employees in more than 150 countries. Its technologies serve more than 72 million patients a year.

You will act as the Quality Core Team Member (QCTM) on new product development programs and speak for quality across design, reliability, supplier, manufacturing, quality systems, software, and post-market quality. You will help shape product decisions and keep programs compliant with quality and regulatory rules across the product lifecycle.

The job is onsite in Jacksonville, Florida.

Responsibilities

• Own quality and reliability strategy, plans, metrics, and risk management for assigned new product development programs.
• Lead the extended quality functions: design quality, software quality, supplier quality, manufacturing quality, and reliability engineering.
• Represent quality on cross-functional core teams and hold final quality authority on assigned projects.
• Drive DRM, DfR, FTQ, and defect prevention from early development onward.
• Find quality and reliability risks, reduce them, and lead root cause investigations and corrective and preventive actions.
• Work with suppliers and manufacturing sites to assess quality risk, inform sourcing decisions, and prepare for launch and lifecycle management.
• Lead compliance planning, assessments, and audit support against quality system and regulatory requirements.
• Support DHF, DMR, PPAP, regulatory submissions, software lifecycle documentation, and product transfer activities.

Requirements

• Bachelor's degree with at least 5 years of technical experience in engineering, quality, technical, or program management, or a Master's degree with at least 3 years in those same areas.
• Experience leading cross-functional product development or quality programs.
• Experience applying risk management, quality, and reliability methods in regulated product development.
• Experience with quality systems, design controls, and product lifecycle management.
• Experience supporting compliance with regulated industry requirements and standards.
• For a bachelor's degree earned outside the United States, the degree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Preferred: Project Management Professional (PMP) certification.
• Preferred: Design Reliability and Manufacturability (DRM) certification or equivalent experience.
• Preferred: First Time Quality (FTQ) certification.
• Preferred: Experience with medical device product development and software development lifecycle processes.
• Preferred: Knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304 requirements.

Conditions

Travel is expected to be under 10% and may include visits to suppliers, manufacturing sites, or project meetings.

U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered only for Principal-level roles and above. Roles below Principal require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

The base salary range is $142,400.00 to $213,600.00 USD for U.S. locations excluding Puerto Rico. The range applies across the United States except Puerto Rico and specific California locations, and the offer may vary by experience, certification or education, market conditions, and location. Pay information applies only to candidates hired in the United States; others receive local market pay and benefits.

This is an office role. You will regularly need to move independently, use a computer, and communicate with peers and co-workers. Reasonable accommodations may be made for people with disabilities. Ask your manager or local HR about conditions specific to your location.

Equal opportunity applies regardless of protected characteristics, including citizenship status, and the Los Angeles County fair chance rules apply to roles with at least two hours of weekly work in unincorporated Los Angeles County.

Benefits

• Eligible for the company's short-term incentive plan, the company Incentive Plan (MIP).
• For regular employees working 20+ hours a 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 or reimbursement, and the Simple Steps well-being program.
• For all regular employees: incentive plans, 401(k) 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 earnings minimums), and Capital Accumulation Plan (for Vice Presidents and above, or subject to IRS earnings minimums).
• Regular employees are those who are not temporary, such as interns. Temporary employees receive paid sick time as required by state law and may join the Employee Stock Purchase Plan. Some benefits may not apply in Puerto Rico.
• More details on benefits and compensation plans are available from the company.