Sr Engineering Project Manager, Sustaining

Masimo•Irvine, CA

6d•$120,000 - $160,000•Onsite

About The Position

The Sr 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.

Requirements

7+ 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.
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.

Nice To Haves

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.

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.