Product Development Engr

Join our dynamic team in Irvine, CA, a vibrant hub for innovation and technology. We are seeking a skilled professional to provide solid technical skills and engineering support for design and development activities for both new and existing products. This role requires working on-site four days a week, offering an opportunity to collaborate closely with a team of experts in the field.

• 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 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 manufacturable products through a 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 quality policies, procedures, and practices as well as with all local, state, federal, and safety regulations, policies, and procedures.

• BS degree in engineering is required (Mechanical or Biomedical Engineering preferred).
• 2-4 years of engineering experience is required in medical devices.
• Good computer skills in usage of MS Office Suite; CAD experience preferred.
• Good documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment required (if applicable).
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Solid problem-solving, organizational, analytical, and critical thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
• Ability to build productive internal/external working relationships.