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

Location: Jacksonville, Florida, United States; onsite work model with less than 10% travel to suppliers, manufacturing sites, or project-related meetings. Candidates must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is available only for Principal-level roles and above.

Salary: $142,400–$213,600 USD annually; eligible for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Serve as the Quality Core Team Member and Voice of Quality for cross-functional new product development programs.
• Lead quality and reliability strategies, plans, metrics, risk management, and compliance activities across the product lifecycle.
• Coordinate design, software, supplier, manufacturing, and reliability quality functions.
• Drive Design Reliability and Manufacturability, Design for Reliability, First Time Quality, and defect-prevention initiatives.
• Lead risk reduction, root-cause investigations, corrective and preventive actions, supplier and manufacturing readiness, and launch activities.
• Support quality-system audits and documentation including DHF, DMR, PPAP, regulatory submissions, software lifecycle records, and product transfers.

Requirements

• Bachelor’s degree and at least 5 years of technical experience in engineering, quality, technical, or program management, 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.
• Experience with quality systems, design controls, and product lifecycle management processes.
• Experience supporting compliance with regulated-industry requirements and standards.
• For bachelor’s degrees earned outside the United States, the degree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Unrestricted U.S. work authorization is required at the time of hire and for the duration of employment.

Nice to have

• Project Management Professional certification.
• Design Reliability and Manufacturability certification or equivalent experience.
• First Time Quality 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.

Culture & Benefits

• Full-time employee position with onsite work in Jacksonville and less than 10% travel.
• Benefits may include health, dental, vision, HSA, FSA, life insurance, disability coverage, tuition assistance, and dependent-care spending accounts for eligible regular employees.
• Regular employees may receive incentive plans, 401(k) contributions and matching, paid time off, paid holidays, employee stock purchase opportunities, and employee assistance.
• Reasonable accommodations are available for qualified individuals with disabilities.