Sr Engineer II, Process

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).

• 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.

• 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 – Solid Works (CSWA), word processing, and spreadsheets.
• Ability to work effectively in cross-functional teams.
• Ability to work onsite Monday - Friday in Irvine, CA.

• Proven experience in taking a major device from inception to customer shipment.
• 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.
• 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.

Bachelor’s degree in engineering:
Mechanical, Electrical, Manufacturing or Industrial Engineering or related field is required.

The anticipated salary range for this position is $120,000 - $155,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.