A large, global, medical device company in Irvine has an opportunity for an Engineer ll for R&D. This Engineer will Support a range of laboratory engineering activities with focus on THV R&D Valve Testing and legacy product modification including feasibility evaluations, product design verification, test method validation, and equipment validation (e.g. standard and custom test equipment). Design, develop, and qualify LabVIEW based software, test fixturing / tooling, test equipment and/or test methods to be used in device qualification testing including writing and executing protocols, statistical data analysis and authoring reports. Partner with THV R&D engineers for device development including: rapidly prototyping designs, evaluating materials, troubleshooting failures, proposing and evaluating design improvements. Identify opportunities for design / re-design of software, test equipment, tools, fixtures, etc. to improve existing test methods and lab processes. Develop and execute feasibility studies, software modification, equipment qualification, test method, software validation and / or product verification protocols / reports and technical reports. May also be responsible for developing test methods and test strategy. May create, update and optimize laboratory test methods and standard operating procedures. Employ use of statistical analysis techniques and statistical experimental design, as appropriate.
• Support a range of laboratory engineering activities with focus on THV R&D Valve Testing and legacy product modification including feasibility evaluations, product design verification, test method validation, and equipment validation (e.g. standard and custom test equipment).
• Working knowledge in developing and maintaining LabVIEW cRIO systems with large number of sensors, such as pressure, flow, thermal and high-speed imaging instrumentation.
• Knowledge of Simple State Machine Architecture, Queues and Notifiers communication methods, XML formatting
• Previous exposure to Automated Test System, LabVIEW RealTime, MATLAB, and Linux OS is highly desirable.
• Proficiency in advanced 3D CAD modelling (Solidworks) using curves and surfaces is required.
• Strong prototyping skills are highly valuable.
• Ability to work well both independently and as a member of a cross-functional team in a dynamic environment is essential.
• Solid problem-solving, organizational, analytical and critical thinking skills.
• Excellent teamwork and interpersonal skills including negotiating and relationship management.
• Must be able to effectively articulate, verbally and in writing, results and conclusions to technical and non-technical personnel. Must have strong technical writing skills.
• Solid understanding and knowledge of engineering principles, theories, and concepts.
• Capability to quickly learn and interpret complex test systems is required.
• Must be a highly motivated self-starter who is driven to achieve quality and value-add results with appropriate direction. Candidate must seek direction when appropriate.
• Ability to build productive internal/external working relationships.
• Clear understanding of good documentation practices and medical device quality system regulations and requirements.
• Working knowledge and understanding of statistical techniques required.
• Proficiency in Microsoft Office Suite and Minitab required.
• Previous experience in medical device testing and/or process development preferred. Prior work experience in a lab environment with flow, pressure, leak, tensile, thermal and other test instrumentation is desirable.
Education and Experience:
• Engineer II level position requires a Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or Electrical Engineering or related engineering discipline.
• 2 years' maximum experience in medical device or similar regulated industry.
• Experience in medical device development, software development for LabVIEW cRio system, software and/or equipment validation and test method validation is required
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.