Product Development Engineer 1

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).

Responsibilities

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

Requirements

0-3 years of engineering experience required, preferably in medical devices; BS degree in Engineering required (Mechanical or Biomedical Engineering preferred); Ability to work onsite 4 days/week in Irvine, CA; 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)

Nice to have

Preferably in medical devices; Mechanical or Biomedical Engineering degree preferred