Engineer II, Process

Danaher•Irvine, CA

8d•Onsite

About The Position

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.

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.

Nice To Haves

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.

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.
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.