Sr Engineer II, Process
MasimoIrvine, California, United States
Posted March 10, 2026
120000 - 155000 USD
About the Company
Masimo is a global medical technology company specializing in noninvasive patient monitoring technologies. With over three decades of innovation, Masimo offers clinically-proven products that enhance clinical decision-making and improve patient safety. The company's focus on solving complex medical challenges sets it apart in the industry.
Job Description
The Sr. Engineer II, Process is responsible for developing, improving, and validating new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to worldwide manufacturing facilities, implements and supports/utilizes effective manufacturing methodologies, such as Lean manufacturing, DFM, visual Workshop, SPC, etc., always following local and international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485:2003).
Requirements
- Assist in setting up World Class Manufacturing capability for the Company’s products.
- Responsible for the design/specification/purchase/installation/qualification of the Company’s manual/ automated assembly equipment and tooling.
- Work closely with design engineering to proactively influence designs for better manufacturability.
- Develop manufacturing plans, project timelines, requirements, specifications, and process flow.
- Generate Manufacturing Assembly and In-Process Acceptance Procedures and train production personnel.
- Develop the Validation Master Plans and perform process validations (IQ, OQ, PQ), including generating protocols and reports.
- Perform line setup, line balancing, and build time studies.
- Lead initial product builds (engineering units, pilot units, process validation units) and coordinate a smooth transfer of new products into production.
- Develop Process Failure Mode and Effects Analyses (PFMEAs).
- Conduct Design Reviews and prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
- Establish Statistical Process Controls for Manufacturing Operations.
- Technically support satellite manufacturing plants through effective communication.
- Drive continuous improvement of engineering technical capabilities.
- Continuously research, learn, and recommend best practices for world-class manufacturing.
- Must be able to travel domestically and internationally.
- Perform special projects as requested.