Product Development Engineer providing technical and engineering support for design and development of new and existing products. Supports product quality, manufacturing, supply continuity, and cost improvement through cross-functional project work. Location: Irvine, CA (Onsite 4 days/week).
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Provide engineering support for design and development activities on new and existing products
Participate in technical and cross-functional project work
Generate novel concepts for new products and performance enhancements
Understand customer needs through literature review, interviews, observation, competitive analysis, and prototype/simulated-use evaluation
Translate customer needs into engineering requirements and product/packaging/process specifications
Develop and execute test methods (measurement equipment, test setup, data analysis)
Write detailed technical reports based on design verification testing
Ensure compliance with quality policies and safety regulations
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0- 3 years of engineering experience required, preferably in medical devices
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Mechanical CAD tools (SolidWorks, CREO, ProE)
Root cause analysis techniques
Statistical tools and computer analysis
Ability to operate and troubleshoot mechanical test equipment
Familiarity with equipment calibration, maintenance, and environmental conditioning chambers
Ability to manage multiple projects while maintaining scope, schedule, budget, and stakeholder alignment
Strong independent and multi-level team collaboration skills
Familiarity with standards/regulations (ISO, FDA, OSHA, ASTM)