Job Summary: The Engineering Project Manager, Sustaining Engineering leads complex cross-functional projects supporting commercially released Masimo products throughout the product lifecycle. This role drives execution a…
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The Sr Engineering Project Manager leads complex cross-functional projects for commercially released medical devices throughout their lifecycle. They are responsible for managing project portfolios, coordinating engineering changes, and ensuring compliance with quality and regulatory standards.
Requirements
Candidates must have 7+ years of project management experience in a regulated industry, preferably medical devices. A bachelor's degree in engineering or a related technical field is required, along with strong skills in risk management and stakeholder coordination.
The Engineering Project Manager, Sustaining Engineering leads complex cross-functional projects supporting commercially released Masimo products throughout the product lifecycle. This role drives execution across sustaining engineering priorities, including design and engineering changes, component obsolescence, supplier qualification, manufacturing transfer, product quality improvements, cost reduction, and business continuity initiatives. The position partners closely with Engineering, Quality, Regulatory, Operations, Manufacturing, Supply Chain, and Product Management to establish priorities, manage risks and dependencies, align resources, and ensure projects are delivered in accordance with business objectives, quality system requirements, and applicable regulatory standards.
Please note this is an onsite position at our Irvine, CA. office.
Duties & Responsibilities:
Lead complex sustaining engineering and product lifecycle projects for commercially released medical devices and accessories from initiation through implementation.
Manage a portfolio of sustaining engineering initiatives, including project scope, priorities, schedules, resources, risks, dependencies, and key deliverables.
Partner with functional leaders to prioritize work and balance product, quality, regulatory, operational, supply continuity, cost, and resource considerations.
Coordinate cross-functional execution of engineering and design changes, ensuring appropriate stakeholder alignment and timely implementation.
Lead projects related to component obsolescence, supplier qualification, alternate sourcing, material changes, and business or supply continuity.
Lead manufacturing transfer, localization, production readiness, cost reduction, and process or product improvement initiatives.
Coordinate project activities supporting CAPA, complaint, reliability, risk management, and product quality improvement efforts, as applicable.
Identify and escalate project risks, tradeoffs, resource constraints, and business impacts; facilitate decisions and drive resolution of competing priorities.
Provide clear project reporting and executive-level communication regarding progress, milestones, risks, decisions, and recommended actions.
Ensure project execution complies with applicable Masimo quality system procedures, Design Controls, change control requirements, and regulatory standards.
Demonstrated experience supporting sustaining engineering and product lifecycle activities such as design changes, manufacturing transfer, supplier qualification, component obsolescence, or supply continuity.
Strong project planning, risk management, problem-solving, stakeholder management, negotiation, and executive communication skills.
Demonstrated ability to influence without direct authority, facilitate cross-functional decision-making, and drive accountability across multiple teams.
Ability to manage multiple concurrent projects and shifting priorities in a fast-paced, highly regulated environment.
Working knowledge of project management and/or product lifecycle tools such as MS Project, Smartsheet, Jira, Agile PLM, Windchill, or similar systems.
Experience supporting Class II medical devices and products within an FDA-regulated environment.
Working knowledge of medical device Design Controls, CAPA, risk management, change control, supplier qualification, manufacturing transfer, and applicable quality system requirements.
Education: Bachelor’s degree in engineering or a related technical discipline, or equivalent combination of education and relevant experience.
Compensation + Benefits: The anticipated range for this position is $106,000 - $140,000. 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, Café. All benefits are subject to eligibility 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.
Physical requirements/Work Environment:
This position primarily works in a laboratory environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.
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 accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
For over 35 years, Masimo has developed innovative monitoring technologies designed to improve patient outcomes and streamline clinical workflows. Today, we continue to build on that legacy—delivering AI-powered solutions to transform how clinicians care for their patients. From the NICU to the operating room to the home, our solutions help clinicians act with clarity and confidence—when and where it matters most.
Masimo is proud to be part of Danaher, a global life sciences and diagnostics innovator committed
to accelerating the power of science and technology to improve human health.
As part of Danaher, Masimo is connected to a uniquely broad ecosystem of expertise, technologies,
and capabilities. Together, we partner closely with customers to help solve their toughest challenges with
greater speed and certainty.
Powered by the Danaher Business System, our advanced science and technology and proven ability to
innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to
discover, develop, and deliver life-changing therapies. Through continuous improvement and operational
excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and
improving quality of life around the world, while building a healthier, more sustainable tomorrow.
Offices: 52 Discovery, Irvine, CA 92618, US
Noninvasive Patient Monitoring TechnologiesHealth CareMedical DeviceBiotechnologyManufacturingHealth Care Products Manufacturing
Based on 1207 listings with disclosed salaries, most engineering jobs in Irvine, CA pay between $43k–$187k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Irvine, CA right now?
There are currently 1,412 open engineering positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Irvine, CA?
Companies currently hiring include Rivian, mouhamedzz, CoStar Group, Young Community Developers, Edwards Lifesciences, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Irvine, CA?
Yes — 401 of the 1412 open engineering positions offer remote or hybrid work (52 remote, 349 hybrid).
How do I apply for Engineering jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.