Engineer II, Process

Job Summary:

The Engineer II, Process supports the development, implementation, validation, and continuous improvement of manufacturing processes and equipment used to produce Masimo products.

The 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.

Please note this is a full time on site position in Irvine, CA.

• 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 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.
• 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 technical or quality risks as appropriate.

• 3-5 years of relevant process, manufacturing, or related engineering experience, prefrably within a regulated manufacturing 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 effectively across Engineering, Manufacturing, and Quality functions.
• Ability to independently execute moderately complex engineering assignments and manage assigned projects with general direction.

• 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.

Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering or technical discipline required; advanced degree preferred.

The anticipated salary range for this position is $90,000 - $115,000 plus benefits. 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.

Masi…