Masimo · 21 hours ago
Sr Engineer II, Process
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $155K/yr
7+ years expMasimo is a company focused on developing innovative medical technologies. The Sr. Engineer II, Process is responsible for developing and validating manufacturing processes, leading new process development, and ensuring compliance with regulatory standards while driving continuous improvement in engineering capabilities.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
At least seven (7) years of experience in engineering: process, manufacturing, or mechanical
Experience with optical/ electro-mechanical assembly and testing
Experience in modern manufacturing principles and techniques
Working knowledge of statistical techniques (e.g., DOE, SPC)
Experience in process automation, verification, and validation
Excellent communication skills and technical writing abilities
Excellent conceptual, analytical, and problem-solving abilities
Excellent computer skills – SolidWorks (CSWA), word processing, and spreadsheets
Ability to work effectively in cross-functional teams
Ability to work onsite Monday - Friday in Irvine, CA
Bachelor's degree in engineering: Mechanical, Electrical, Manufacturing or Industrial Engineering or related field is required
Preferred
Proven experience in taking a major device from inception to customer shipment
Proven work experience in process engineering
Working Knowledge of 21 CFR, Part 820, and ISO 13485:2003 requirements
Must be comfortable with integrating new technology into an existing business environment
Experience with design, development, and validating manufacturing processes for an optical/ electro-mechanical device containing software
Experience with cable assembly processes including cable preparation, hand soldering, crimping etc
Experience with plastic injection molding
Excellent CAD (SolidWorks) skills, CSWP
Working knowledge of Geometric Dimensioning and Tolerancing (GD&T)
Demonstrated ability to manage large-scale projects and deliver results on time and within budget
Design experience (the ability to design for manufacturability)
Basic device software knowledge
Benefits
Up to 10% annual bonus based on Company, department, and individual performance.
Company
Masimo
Masimo Corporation, a medical technology company, develops, manufactures, and markets noninvasive patient monitoring products.
1001-5000 employees
H1B Sponsorship
Masimo has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (24)
2023 (27)
2022 (25)
2021 (24)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$754.95MKey Investors
Politan Capital ManagementRobecoBill & Melinda Gates Foundation
2022-08-15Post Ipo Equity· $750M
2017-08-26Post Ipo Equity
2016-11-11Grant· $4.95M
Leadership Team
Michelle Brennan
Independent Director
Recent News
2025-12-08
Orange County Business Journal
2025-12-07
2025-12-05
Company data provided by crunchbase