Sr Quality Engineer, NPD​/NPI

Job Summary:

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.

• 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, escal, 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

• 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.

• Experience supporting Class II and/or Class III medical device development.
• Experience with design transfer, manufacturing readiness, and…