Engineering Project Manager, Sustaining

Masimo Medical Technologies (Malaysia) Sdn. Bhd.; Irvine (CA); On-site; USD 106,000 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life/AD&D

401(k)

Vacation

Paid Maternity Leave

Flexible Spending Accounts

On-site Wellness Clinic

Fitness Center

Cafe

Pet Insurance

Job summary

Masimo seeks an Engineering Project Manager in Irvine, CA, to lead complex sustaining engineering and lifecycle projects for medical devices. You will drive design changes, manufacturing transfers, supplier qualification, and cost reduction while ensuring compliance with quality systems and regulations.

The role partners with multiple functions to align priorities and manage risks. Requirements include 3–5+ years in project management within regulated environments, strong communication, and

Qualifications

• Experience leading complex cross-functional initiatives in medical devices or regulated fields.
• Supports sustaining engineering and product lifecycle activities such as design changes and supplier qualification.
• Strong planning, risk management, problem solving, and executive communication skills.
• Ability to influence without direct authority and manage multiple priorities.

Responsibilities

• Lead complex sustaining engineering and product lifecycle projects from initiation to implementation.
• Manage a portfolio of sustaining initiatives with scope, priorities, schedules, and resources.
• Coordinate cross-functional execution of engineering and design changes with stakeholders.
• Drive activities for component obsolescence, supplier qualification, and alternate sourcing.
• Oversee manufacturing transfer, localization, and production readiness initiatives.
• Support CAPA, complaints, reliability, and quality improvement efforts as applicable.
• Provide clear project reporting and executive-level progress updates.

Skills

Cross-functional leadership

Risk management

Stakeholder management

Executive communication

Multi-project management

Regulated environment experience

Education

Bachelor’s degree in engineering

Tools

MS Project

Smartsheet

Jira

Agile PLM

Windchill

Job description

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 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 elevate 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.

Minimum Qualifications:

• 3-5+ years of project or program management experience, including experience leading complex cross-functional initiatives in the medical device, life sciences, or other regulated industry.
• 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.

Preferred Qualifications:

• PMP or other recognized project management certification.
• 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.

Language 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.