Sr Manager, NPI Quality Engineering

Manager, New Product Quality leads and develops a team of New Product Quality Engineers responsible for ensuring the quality and regulatory compliance of medical device products from early-stage design through commercial launch and robust quality system processes that support new product introduction (NPI), preservation of design intent, and readiness for regulatory submissions and The role operates at the intersection of R&D, Regulatory Affairs, and Manufacturing, driving quality planning, design assurance activities, and risk management execution across the full product development lifecycle — including post-launch monitoring and stability validation through commercial steady Lead quality planning activities across the product development lifecycle, including development of Quality Plans, Design History Files (DHFs), and risk management documentation in accordance with ISO 14971 * validation planning and execution, and ensuring traceability from user needs Own quality inputs to regulatory submissions (510(k), De Novo, PMA as standards and FDA/international requirements * specifications, and validations are established and documented prior to commercial launch * Lead post-launch stability monitoring activities, including coordinating surveillance data review, complaint trending, and corrective action as needed through commercial steady state * Own and oversee quality input to design and process changes during Ensure design intent and essential performance are preserved across design ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented * Collaborate with Regulatory Affairs, R&D, Clinical, Manufacturing Engineering, Operations, and Supply Chain to ensure seamless NPI execution Partner with Supplier Quality on supplier qualification and selection activities supporting new products, including quality agreements, incoming inspection strategy, and supplier change evaluation * Provide escalation support for significant quality issues arising during regulatory compliance, or program timelines * Lead, mentor, and develop a team of New Product Quality Engineers; priorities, goals, and performance expectations aligned with program milestones and quality objectives * Ensure appropriate staffing, training, and competency development to support Direct experience leading quality or engineering functions supporting new product development and commercial launch of regulated medical devices

* Strong working knowledge of design controls, risk management (ISO 14971), verification and validation planning, and design transfer requirements

* Demonstrated experience with regulatory submissions (510(k), PMA, or equivalent) and familiarity with FDA and international regulatory Solid understanding of CAPA, nonconformance management, change control, and root cause analysis methodologies as applied in a development and launch clearly convey complex quality and regulatory concepts to cross-functional Strong organizational and prioritization skills with the ability to manage maintenance and traceability, and understanding of DHF/DMR structure and document control requirements

Experience in patient monitor systems, hospital-based products, software or electronic device products;

* Experience with FDA/GMP requirements for medical device;

* Experience leading teams through regulatory inspections or notified body Bachelor’s degree in a technical discipline required, or an equivalent combination of education, training, and relevant professional experience.

also qualifies for up to 15% annual bonus based on Company, department, and individual performance. Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Language requirements

* Ability to read, write, and communicate effectively in English. * Ability to interpret technical documents, schematics, and written Ability to clearly document technical findings and communicate with This position primarily works in an office environment and requires frequent Daily use of a computer and other digital facilitating meetings or walking through facilities.

with real or perceived disabilities to perform the essential functions of the Masimo is proud to be an EEOE/, M/F/D/V, and we are committed to Diversity at