Sr Engineer, Process, Test

Job Summary JOB DESCRIPTION The Sr Engineer, 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 & ResponsibilitiesDevelop 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 Qualifications5+ years of experience in new product introduction of electro-mechanical, programmed and software configured productsHands –on experience with design and development of manufacturing test systemsExperience with Design for Manufacturability Assembly and Test (DFM/A/T)Experience with Statistical software- Minitab/JMPExcellent Mechanical design skills – SolidWorks Excellent Test Software design skills –NI LabVIEW, Visio and Microsoft OfficeGood communication skills, both verbal and written, and the ability to effectively interface within a cross-functional team environmentExcellent conceptual, analytical, and problem-solving abilityExperienced in modern manufacturing principles and techniquesWill be required to travel both domestically and internationally (including Mexico), on a periodic basisMust be able to lift and carry up to 30 poundsAbility to work onsite Monday - Friday in Irvine, CAPreferred QualificationsMasters in EngineeringExperience 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 queriesKnowledge of FDA regulations 21 CFR part 11 and part 820EducationBachelor’s degree in engineering: Electrical, Mechanical, Computer, or Industrial Engineering or related field is required.CompensationThe anticipated salary range for this position is $110,000 - $130,000 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.