Process Engineer II – On-Site Manufacturing (Irvine)

Masimo Medical Technologies (Malaysia) Sdn. Bhd.; Irvine (CA); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life/AD&D

Disability Insurance

401(k)

Vacation

Sick leave

Holiday

Paid Maternity Leave

Flexible Spending Accounts

Voluntary Accident Insurance

Critical Illness Insurance

Hospital Insurance

Long-Term Care

Employee Assistance Program

Pet Insurance

On-site wellness clinic

Fitness center

Cafe

Job summary

Masimo Medical Technologies (Malaysia) Sdn. Bhd. seeks an Engineer II, Process to develop, validate, and optimize manufacturing processes and equipment for Masimo products at the Irvine, CA site.

The role emphasizes data-driven problem solving to improve quality, efficiency, and manufacturability while supporting new product introduction and sustaining manufacturing activities in a regulated environment. This full-time on-site position in Irvine, CA, requires collaboration with Mechanical

Qualifications

• 3-5 years of relevant process, manufacturing, or related engineering experience in a regulated environment.
• 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.
• Strong analytical, technical writing, and communication skills with the ability to work across Engineering, Manufacturing, and Quality functions.
• Ability to independently execute moderately complex engineering assignments and manage projects with general direction.

Responsibilities

• 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.
• Develop and execute process and equipment qualification and validation activities, including protocols, reports, test methods, and associated manufacturing documentation.
• Provide technical support to Manufacturing and Operations and collaborate cross-functionally with Mechanical Design, Quality, Regulatory, Supply Chain, and other functions to resolve technical issues and support business objectives.
• Investigate manufacturing and process issues, perform root cause analysis, and implement corrective and preventive actions with Quality and Manufacturing teams.
• Identify and implement continuous improvement and cost-reduction opportunities related to yield, cycle time, scrap, labor efficiency, equipment utilization, and overall process performance.
• Design, evaluate, and support the implementation of semi-automated and automated manufacturing equipment, tooling, and fixtures as appropriate.
• Create and maintain manufacturing documentation, including work instructions, specifications, procedures, process parameters, drawings, and engineering change documentation.
• Apply statistical methods and process controls to evaluate manufacturing performance, identify variation, establish process capability, and drive improvements.
• Independently execute moderately complex engineering assignments and projects, analyze technical data, communicate findings and recommendations, and elevate significant risks.

Skills

Process engineering

Manufacturing engineering

Statistical analysis

Root cause analysis

Structured problem solving

Cross-functional communication

Project execution

Education

Bachelor’s degree in Mechanical Engineering or related field

Tools

Statistical analysis software

Microsoft Excel

Job description

Masimo Medical Technologies (Malaysia) Sdn. Bhd. seeks an Engineer II, Process to develop, validate, and optimize manufacturing processes and equipment for Masimo products at the Irvine, CA site.

The role emphasizes data-driven problem solving to improve quality, efficiency, and manufacturability while supporting new product introduction and sustaining manufacturing activities in a regulated environment. This full-time on-site position in Irvine, CA, requires collaboration with Mechanical