Engineering Project Manager, Sustaining
Danaher Corporation
Summary
The Engineering Project Manager, Sustaining, 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.
Job description
This position reports to the VP, Project Management and is part of the Engineering department located in Irvine, CA and will be an on-site role.
In This Role, You Will Have The Opportunity To:
- 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.
The Essential Requirements Of The Job Include:
- B.S. Degree in engineering or a related technical discipline, with 3+ 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.
- Working knowledge of project management and/or product lifecycle tools such as MS Project, Smartsheet, Jira, Agile PLM, Windchill, or similar systems.
It would be a plus if you also possess previous experience in:
- 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.
Requirements
- B.S. Degree in engineering or a related technical discipline
- 3+ years of project or program management experience
- 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
- Working knowledge of project management and/or product lifecycle tools such as MS Project, Smartsheet, Jira, Agile PLM, Windchill, or similar systems
- PMP or other recognized project management certification (preferred)
- Experience supporting Class II medical devices and products within an FDA-regulated environment (preferred)
- Working knowledge of medical device Design Controls, CAPA, risk management, change control, supplier qualification, manufacturing transfer, and applicable quality system requirements (preferred)
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Annual bonus up to 10%
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.