Job Description

Job Tiitle: R&D Engineer - Medical device

Location: Los Angeles, CA 100% Onsite

Duration: 12 Months

Employment Type: W2 Contract

Rate: $40- $45/hr W2

Experience: 4+ Years preferred

Position Overview:

We are seeking an R&D Engineer II to support in-vitro test system development, test method integration, qualification, and validation activities within a regulated medical device environment.

The ideal candidate will have experience with CAD design, test system development, test method validation, laboratory testing, and cross-functional collaboration. Experience with SolidWorks, Gage R&R, and Measurement System Analysis (MSA) is highly preferred.

Key Responsibilities:

• Support the design and development of a new in-vitro test system to replace a legacy system
• Improve testing capacity and functionality of the new test system
• Integrate new test methods into established testing procedures
• Support qualification and validation of new test systems and test methods
• Collaborate with In-Vitro Testing, Product Development, EHS, Quality, and Facilities teams to gather requirements
• Develop project timelines, milestones, resource requirements, and implementation plans
• Design new test system setups using SolidWorks or other CAD software
• Develop and maintain CAD drawings and technical documentation
• Develop validation frameworks and support activities such as IQ, EQV, and TMV
• Execute test method validation activities with support from the existing laboratory team
• Perform and support Gage R&R and other Measurement System Analysis (MSA) activities
• Troubleshoot test systems and support improvements to testing processes
• Analyze test results and support accurate, reliable, and reproducible testing
• Collaborate with cross-functional teams to ensure successful implementation of the new test setup

Required / Preferred Qualifications:

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical field preferred
• Experience with R&D, laboratory testing, or test engineering
• Experience with CAD software; SolidWorks experience preferred
• Familiarity with test methods and test system development
• Experience with test method validation
• Experience with Gage R&R and Measurement System Analysis (MSA)
• Understanding of equipment qualification and validation activities
• Experience working in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment is preferred
• Strong technical documentation and communication skills
• Ability to work effectively with cross-functional teams
• Strong analytical, troubleshooting, and problem-solving skills

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