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Company

Original Job Post

Masimo · 1 week ago

Engineer II, Process

Irvine, CA

Full-time

Onsite

Mid Level

$80K/yr - $120K/yr

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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 affective 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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Optical AssemblyElectro-Mechanical AssemblyManufacturing PrinciplesStatistical TechniquesProcess AutomationValidationSolidworksWord ProcessingSpreadsheetsProblem-SolvingCommunicationTeamworkProcess Engineering21 CFR Part 820ISO 13485 2003Technology IntegrationDesign DevelopmentManufacturing ProcessesOptical Electro-mechanical DeviceSoftware ValidationCable AssemblyHand SolderingCrimpingPlastic Injection MoldingCAD (Solidworks)CSWPGeometric Dimensioning Tolerancing (GD&T)Project ManagementDesign for ManufacturabilityDevice Software

Required

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

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

Company

Masimo

Glassdoor

3.1

Masimo Corporation, a medical technology company, develops, manufactures, and markets noninvasive patient monitoring products.

Founded in 1989

Irvine, California, USA

1,001-5,000 employees

http://www.masimo.com

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

Trends of Total Sponsorships

2023 (13)

2022 (25)

2021 (22)

2020 (33)