Sr Engineer II, Process

Masimo•Irvine, CA

13d•Onsite

About The Position

Job Summary: 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

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.

Nice To Haves

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.

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.