Product Development Engineer

Job Description:
Product Development Engineer
Irvine, CA 92618

Overview:
Provide solid technical skill and engineering support for design and development activities for new and existing products.
Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
Participate in executing technical and/or cross-functional project work.
Contribute to a culture of innovation by proactively generating Client concepts for new products and enhancements to current product performance. Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
Translate customer needs into engineering requirements into specific product, packaging and process specifications.

Engineer robust and manufactural products through strong understanding and application of engineering fundamentals. Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
Ensure compliance with Client quality policies, procedures and practices as well as with all local, state, federal and Client safety regulations, policies and procedures.

BS degree in engineering is required (Mechanical or Biomedical Engineering preferred). 0-3 years of engineering experience is required, preferably in medical devices. Demonstrated ability to utilize statistical tools and computer analysis.

" Ability to use Mechanical CAD tools (SolidWorks, CREO, ProE).', 'Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.', 'Developing root cause analysis techniques. Familiar with standards and regulations (ISO, FDA, OSHA, ASTM). " Can operate and troubleshoot mechanical test equipment in the lab.
Developing in the operation of environmental conditioning chambers, equipment calibration and maintenance.'