Sr Quality Engineer, NPD/NPI

Masimo•Irvine, CA

9h•$105,000 - $135,000•Onsite

About The Position

The Sr. Quality Engineer, NPD/NPI is responsible for ensuring design quality and regulatory compliance throughout the new product development lifecycle for Masimo products. This position provides quality engineering support across cross-functional development teams through design control documentation, process execution, and risk management activities, while coordinating with Sustaining Quality and Regulatory Affairs as required to ensure successful and compliant product launches.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related technical discipline, or equivalent combination of education and experience required.
Minimum 6–8+ years of quality engineering experience within a regulated medical device or similarly regulated environment.
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and quality system principles.
Demonstrated experience supporting new product development, design transfer, validation, and commercialization activities.
Proven experience authoring and managing design control documentation including DHF records, risk files, protocols, reports, and engineering documentation.
Experience with quality management systems (QMS), including CAPA, nonconformance management, change control, and document control processes.
Strong analytical, problem-solving, and root cause investigation skills.
Ability to manage multiple priorities independently in a fast-paced, cross-functional development environment.
Strong written and verbal communication skills, with the ability to effectively communicate technical and compliance information across all levels of the organization.
ABILITY TO READ, WRITE, AND COMMUNICATE EFFECTIVELY IN ENGLISH.
ABILITY TO INTERPRET TECHNICAL DOCUMENTS, ENGINEERING DATA, SCHEMATICS, AND WRITTEN PROCEDURES.
ABILITY TO CLEARLY DOCUMENT TECHNICAL FINDINGS AND EFFECTIVELY COMMUNICATE ACROSS CROSS-FUNCTIONAL TEAMS.

Nice To Haves

Experience supporting Class II and/or Class III medical device development.
Experience with design transfer, manufacturing readiness, and NPI implementation activities.
Familiarity with FDA submission pathways, including 510(k), PMA, or De Novo.
Experience supporting FDA inspections, ISO audits, supplier audits, or Notified Body interactions.
Familiarity with IEC 60601, IEC 62366, ISO 80601 series, or other applicable product-specific standards.
ASQ Certified Quality Engineer (CQE) or equivalent professional certification preferred.
Familiarity with Agile, phase-gate, or structured product development methodologies within a regulated environment.

Responsibilities

Lead quality engineering activities across assigned new product development programs, ensuring compliance with applicable regulatory requirements, quality system procedures, and industry standards throughout the product lifecycle
Author, review, and approve quality documentation including design control records, risk management files, test protocols, test reports, and product specifications in support of program milestones and design reviews
Serve as the quality representative on cross-functional project teams, providing guidance on design control requirements, regulatory strategy, and quality risk considerations from concept through commercial release
Identify, escalate, and drive resolution of quality and compliance issues encountered during product development, applying structured problem-solving methodologies to determine root cause and implement effective corrective actions
Plan and support design verification and validation activities, including protocol development, execution oversight, and results review, to ensure products meet defined user needs and intended use requirements
Support internal and external audits by preparing documentation, responding to findings, and leading corrective action efforts within areas of responsibility
Initiate, track, and manage nonconformances, CAPAs, and engineering changes through the quality management system, ensuring timely closure and effectiveness verification
Maintain and improve quality system procedures and work instructions within areas of assigned responsibility, ensuring alignment with current regulatory requirements and best practices
Mentor junior quality engineers on design control processes, documentation standards, and quality system requirements, supporting team capability development
Collaborate with Regulatory Affairs, R&D, Operations, and Supply Chain to ensure quality requirements are effectively integrated into product and process design decisions
Monitor and communicate product and program quality metrics, proactively identifying trends and recommending corrective or preventive actions as appropriate
Support post-market quality activities, including complaint investigations, field corrective actions, and design changes, ensuring continuity between development and sustaining quality functions