Location: 120 South State College Boulevard, Brea CA 92821
Duration: 12 months on W2
Shift Timings: 8am-5pm
Mostly on-site due to the need to be in the lab for test method development/validation activities. Remote work is acceptable for tasks that can be performed remotely
Job Description
This position will be a core part of design verification and validation (V&V) team focusing on developing design verification plans, protocols and review/evaluation of design history files for disposable IV product line.
Working under a general direction of the V&V Manager, the R&D engineer will review and select groups of products that will undergo design verification tests.
Support the cross-functional project team with R&D activities and deliverables. In addition, the R&D engineer is expected to have a working knowledge in developing and validation of test methods required for design verification.
Apply Mechanical/Medical Device engineering knowledge to rationalize selection of representative performance verification tests based on product design characteristics and requirements.
Develop and execute test protocols while working closely with engineers and lab technicians on the team. And Interact with product development and R&D teams to leverage engineering fundamentals and shared experience.
Qualifications
Graduating Engineer or B.S. Degree in Mechanical Engineering or Biomedical Engineering with experience in developing test protocols and test methods
Minimum of 3 years of post-educational product design and development experience
Experience in Medical Device Design Control procedures.
2-3 years of experience with test method development/validation in medical device industry
2-3 years of experience with design verification planning, developing protocols & execution
Experience with planning and executing design verification activities (e.g. Design Verification Plans, Design Verification Protocols, Test Method Development and Validation)
Knowledge of statistical analysis of experimental data and inferential statistics
Eagerness to work on broad and challenging engineering assignments involving analytical reasoning, test protocol development and execution
Experience working in a lab environment, testing mechanical components, experience working in high volume plastics manufacturing.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Human Resources Services
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