Sr Engineer II, Process, Test

Job Summary

The Sr Engineer II, Process - Test is responsible for timely introduction of new and existing test systems into the manufacturing environment while ensuring the highest levels of quality and reliability. This position will influence new product design teams to improve design for test. The incumbent will also define, implement and validate product test processes to support the introduction of new and existing products into a lean manufacturing environment.

Duties & Responsibilities

• Develop electro-mechanical and/or pneumatic test equipment/systems to be deployed in a medical device manufacturing environment.
• Design test systems suitable for High Mix-Low Volume products, as well as Low Mix-High Volume products.
• Lead system-level integration of hardware, tooling/fixture, and test software to ensure highly repeatable and reliable test system performance.
• Work closely with cross-functional departments to define test system requirements to ensure product meets specifications and to mitigate any potential product and process risks.
• Develop test systems with clear and standardized operator interfacing to reduce production errors and risks.
• Define requirements for test software to align with the functional needs of test system.
• Develop benchtop test software to interface with test hardware and equipment to conduct development studies.
• Develop clear and concise pictorial instructions and procedures for test systems to be deployed in production environment.
• Participate in Process Failures Modes and Effect Analysis (PFMEA) reviews to ensure effective risk coverage is provided by the test system(s).
• Work closely with design R&D and production for DFM / DFT.
• Define and execute test method validations (TMV), including generating protocols and reports.
• Drive improvement and standardization projects across test systems and documentation to enhance consistency and scalability.
• Conduct Design Reviews and prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
• Train production personnel and production engineers on equipment installation and execution of the test system.
• Collaborate with process engineers on deployment of new test systems to ensure smooth transition into production.
• Technically support satellite-manufacturing plants with test equipment debugging, improvements and/or duplication efforts.
• Leverage SPC tools like Gage R&R, DOE's, Capability Analysis etc.to drive data-informed decisions and optimize test processes.
• Query SQL databases to collect and analyze test data for troubleshooting, development and test improvements.
• Continuously research, learn, and recommend best practices for world-class manufacturing.
• Must be able to travel domestically and internationally.
• Perform special projects as requested.

Minimum Qualifications

• 8 years of experience in new product introduction of electro-mechanical, programmed and software configured products
• Hands -on experience with design and development of manufacturing test systems
• Experience with Design for Manufacturability Assembly and Test (DFM/A/T)
• Experience with Statistical software- Minitab/JMP
• Excellent Mechanical design skills - SolidWorks
• Excellent Test Software design skills -NI LabVIEW, Visio and Microsoft Office
• Good communication skills, both verbal and written, and the ability to effectively interface within a cross-functional team environment
• Excellent conceptual, analytical, and problem-solving ability
• Experienced in modern manufacturing principles and techniques
• Will be required to travel both domestically and internationally (including Mexico), on a periodic basis
• Must be able to lift and carry up to 30 pounds
• Ability to work onsite Monday - Friday in Irvine, CA

Preferred Qualifications

• Masters in Engineering
• Experience with Electro-Mechanical and Software based products, Operating Systems (Windows)
• Certified SolidWorks Associate (CSWA)
• Certified LabVIEW Developer (CLD)
• Working knowledge with NI TestStand, Python, Windows, Networking (Local and Global), SQL Database, SQL queries
• Knowledge of FDA regulations 21 CFR part 11 and part 820

Education

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

Compensation

The anticipated salary range for this position is $115,000 - $140,000 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.

Psychical Requirements/Work Environment

This position primarily works in an office environment but will spend a fair amount of time in a production environment. Must be able to travel on a periodic basis both domestically and internationally (including Mexico). The ability to operate a motor vehicle and maintain a valid Driver's license is required. Daily use of a computer and other computing and digital devices is required. May stand or sit for extended periods and require being able to lift/carry up to 30 lbs.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.