Sr Manager, NPI Quality Engineering

Masimo•Irvine, CA

23h•$140,000 - $175,000•Onsite

About The Position

The Sr. 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 launch stability. This role is accountable for establishing and maintaining robust quality system processes that support new product introduction (NPI), preservation of design intent, and readiness for regulatory submissions and audits. 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 state.

Requirements

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 expectations for product development documentation
Solid understanding of CAPA, nonconformance management, change control, and root cause analysis methodologies as applied in a development and launch stability context
Excellent verbal and written communication skills, with the ability to clearly convey complex quality and regulatory concepts to cross-functional stakeholders and executive leadership
Strong organizational and prioritization skills with the ability to manage multiple concurrent programs and competing deadlines
Excellent documentation practices, including attention to detail, record maintenance and traceability, and understanding of DHF/DMR structure and document control requirements
Ability to read, write, and communicate effectively in English.
Ability to interpret technical documents, schematics, and written instructions.
Ability to clearly document technical findings and communicate with cross-functional team members.

Nice To Haves

Experience in patient monitor systems, hospital-based products, software or electronic device products
Experience with FDA/GMP requirements for medical device
Strong working knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR
Experience leading teams through regulatory inspections or notified body audits

Responsibilities

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
Drive design assurance activities including design reviews, verification and validation planning and execution, and ensuring traceability from user needs through design outputs
Own quality inputs to regulatory submissions (510(k), De Novo, PMA as applicable), ensuring completeness, accuracy, and alignment with applicable standards and FDA/international requirements
Oversee design transfer activities, ensuring manufacturing processes, specifications, and validations are established and documented prior to commercial launch
Ensure manufacturing processes introduced through NPI are executed in accordance with approved procedures, specifications, and process validations (IQ/OQ/PQ)
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 development and the launch stability period (ECOs, deviations, waivers), ensuring thorough impact assessments determine verification, validation, and documentation requirements
Ensure design intent and essential performance are preserved across design iterations, supplier selections, and manufacturing scale-up
Oversee evaluation of design and process decisions for impact to patient, user, and operator safety; ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented
Ensure compliance with applicable regulations and standards throughout the product development lifecycle, including ISO 13485, FDA 21 CFR 820/QMSR, EU MDR (as applicable), IEC 60601-1, and IEC 62304 (as applicable)
Collaborate with Regulatory Affairs, R&D, Clinical, Manufacturing Engineering, Operations, and Supply Chain to ensure seamless NPI execution and on-time launch readiness
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 development or the launch stability period that impact product safety, regulatory compliance, or program timelines
Lead, mentor, and develop a team of New Product Quality Engineers; set clear priorities, goals, and performance expectations aligned with program milestones and quality objectives
Ensure appropriate staffing, training, and competency development to support a growing NPI portfolio