Sr Quality Engineer, NPD/NPI

Masimo Corporation; Irvine (CA); On-site; USD 105,000 - 135,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

401(k)

Paid Time Off

Maternity Leave

Wellness Clinic

Fitness Center

On-site Café

Job summary

Masimo Corporation in Irvine, CA seeks a Sr. Quality Engineer for NPD/NPI to ensure design quality and regulatory compliance across the development lifecycle.

You will lead quality activities, author design control docs, manage risks, support audits, and mentor junior engineers while collaborating with R&D, Regulatory Affairs, Operations, and Supply Chain. A Bachelor's degree and 6-8+ years in regulated medical devices, knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and QMS is required;

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline, or equivalent.
• 6-8+ years of quality engineering experience in regulated medical devices.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Experience with design development, transfer, validation, and commercialization.
• Authoring and managing design control documentation including DHF, risk files, protocols, reports.
• Experience with QMS processes: CAPA, nonconformance, change control, document control.
• Strong analytical and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.

Responsibilities

• Lead quality engineering activities across NPD programs ensuring regulatory and quality system compliance.
• Author, review, and approve design control records, risk management files, test protocols/reports, and specifications.
• Serve as the quality representative on cross-functional teams providing guidance on design control and regulatory strategy.
• Identify and resolve quality/compliance issues using root cause analysis.
• Plan and support design verification and validation activities.
• Support internal/external audits and drive corrective actions.
• Manage nonconformances, CAPAs, and engineering changes.
• Mentor junior quality engineers on design control and QMS requirements.
• Collaborate with Regulatory Affairs, R&D, Operations, and Supply Chain to integrate quality requirements into design decisions.
• Monitor quality metrics and drive corrective/preventive actions.
• Support post-market quality activities.

Skills

Quality engineering

Regulatory compliance

Design control

Risk management

CAPA

Root cause analysis

QMS

Cross-functional teamwork

Documentation

Communication

Education

Bachelor's degree in Engineering/Life Sciences

Tools

QMS software

Job description

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.

Duties & 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, elevate, 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

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

Education:

Bachelor's degree in Engineering, Life Sciences, or related technical discipline, or equivalent work experience.

Compensation

The anticipated salary range for this position is $105,000 - $135,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% 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 Wellness Clinic, Fitness Center, Cafe. All benefits are subject to eligibility requirements.

Language requirements

• 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.

Physical requirements/Work Environment

• This position primarily works in an office environment and requires frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may require standing for extended periods when facilitating meetings, supporting laboratory activities, or walking through facilities.
• Must be able to move throughout office, laboratory, and light manufacturing environments as needed to support design reviews, product inspections, audits, and cross-functional collaboration.
• Occasional lifting and carrying of materials or equipment up to 25 lbs. may be required.
• Domestic and international travel up to 20-25% may be required to support supplier visits, audits, customer activities, or program-related meetings.
• The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EEOE/, M/F/D/V, and we are committed to Diversity at the corporate level.