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