Product Development Engineer 1
Roles & 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
Experience Required
- 0- 3 years of engineering experience required, preferably in medical devices
Skills & Certifications
- 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)
Eligibilities & qualifications
- BS degree in Engineering required (Mechanical or Biomedical Engineering preferred)
- Ability to work onsite 4 days/week in Irvine, CA
- No drug screening required
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