Engineer II, Process
Danaher Corporation
Summary
The Engineer II, Process will be responsible for the development, implementation, validation, and continuous improvement of manufacturing processes and equipment used to produce Masimo products. This role applies engineering principles and data-driven problem solving to improve process capability, quality, efficiency, and manufacturability while supporting new product introduction and sustaining manufacturing activities in compliance with applicable quality and regulatory requirements. This position reports to the Director, Process Engineering and is part of the Process Engineering team located in Irvine, CA and will be an on-site role.
Job description
In this role, you will have the opportunity to:
- Develop, implement, and optimize manufacturing processes, methods, tooling, fixtures, and equipment to support production requirements and product quality.
- Support the introduction and scale-up of new products and processes from development through manufacturing, including assessment of manufacturability, process capability, and production readiness.
- Investigate manufacturing and process issues, perform root cause analysis, and implement effective corrective and preventive actions in partnership with Quality, Manufacturing, and other engineering teams.
- Identify and implement continuous improvement and cost-reduction opportunities related to yield, cycle time, scrap, labor efficiency, equipment utilization, and overall process performance.
The essential requirements of the job include:
- 3+ years of relevant process, manufacturing, or related engineering experience, preferably within a regulated manufacturing environment.
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering or technical discipline required
- Experience with manufacturing process development, process improvement, validation, and/or production support.
- Working knowledge of statistical process control, process capability, root cause analysis, and structured problem-solving methods.
It would be a plus if you also possess previous experience in:
- Experience in the medical device, life sciences, or other highly regulated manufacturing industry.
- Experience with new product introduction, manufacturing transfer, and/or production scale-up.
- Experience with electromechanical or optical products, process automation, equipment qualification, tooling, or fixtures.
- Knowledge of FDA Quality System requirements, ISO 13485, Lean/Six Sigma, DOE, and/or DFM/DFA methodologies.
Requirements
- 3+ years of relevant process, manufacturing, or related engineering experience, preferably within a regulated manufacturing environment.
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering or technical discipline required
- Experience with manufacturing process development, process improvement, validation, and/or production support.
- Working knowledge of statistical process control, process capability, root cause analysis, and structured problem-solving methods.
- Experience in the medical device, life sciences, or other highly regulated manufacturing industry.
- Experience with new product introduction, manufacturing transfer, and/or production scale-up.
- Experience with electromechanical or optical products, process automation, equipment qualification, tooling, or fixtures.
- Knowledge of FDA Quality System requirements, ISO 13485, Lean/Six Sigma, DOE, and/or DFM/DFA methodologies.
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
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.