Sr Manager, NPI Quality Engineering (MedTech)

TL;DR

Sr Manager, NPI Quality Engineering (MedTech): Leading a team of New Product Quality Engineers to ensure quality and regulatory compliance of medical device products from early-stage design through commercial launch. Focus on design assurance, risk management execution, and ensuring readiness for FDA and international regulatory submissions.

Location: Onsite in Irvine, CA, United States

Salary: $140,000 - $175,000

Company

hirify.global is a medical technology company specializing in noninvasive monitoring and healthcare solutions.

What you will do

• Lead quality planning across the product development lifecycle, including the development of Quality Plans and Design History Files (DHFs).
• Drive design assurance activities, including design reviews and verification/validation (V&V) planning and execution.
• Own quality inputs for regulatory submissions such as 510(k), De Novo, and PMA, ensuring alignment with FDA and international requirements.
• Oversee design transfer activities and ensure manufacturing processes are validated through IQ/OQ/PQ.
• Manage post-launch stability monitoring, including complaint trending and corrective actions through commercial steady state.
• Lead, mentor, and develop a team of New Product Quality Engineers, setting priorities and performance expectations.

Requirements

• Direct experience leading quality or engineering functions for the development and launch of regulated medical devices.
• Strong expertise in design controls, ISO 14971 risk management, and V&V planning.
• Demonstrated experience with FDA regulatory submissions and international product development documentation.
• Solid understanding of CAPA, nonconformance management, and root cause analysis methodologies.
• Bachelor’s degree in a technical discipline.
• Must be based in or able to work onsite in Irvine, CA, United States.

Nice to have

• Experience with patient monitor systems, hospital-based products, or electronic medical devices.
• Deep working knowledge of ISO 13485 and EU MDR.
• Experience leading teams through regulatory inspections or notified body audits.

Culture & Benefits

• Competitive compensation with an annual bonus of up to 15%.
• Comprehensive health coverage including Medical, Dental, and Vision insurance.
• Financial benefits such as a 401(k) plan and Flexible Spending Accounts.
• Generous paid leave including Vacation, Sick, and Holiday time, as well as Paid Maternity Leave.
• On-site perks including a Wellness Clinic, Fitness Center, and Café.