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Staff R&D Process Engineer
Job Description
Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Staff R&D Process Engineer on a 9-month+ Contract. Our client offers results-driven people a place where they can make a difference – every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in a highly collaborative and professional environment.
The experienced Design Engineer will be responsible for designing, validating and bringing new products to market. Seeking a skilled R&D Development Engineer to support the scale-up and introduction of new material (Resin) for product use in Pulmonary Embolism procedures. This role focuses on developing, optimizing, and validating robust manufacturing processes to ensure product quality, reliability, and regulatory compliance.
This role is fully onsite role in Irvine, CA with the expectation to be in office 5 days a week.
Position Description (Principal Duties and Responsibilities)
- Develop, optimize, and document manufacturing processes for electro-mechanical assemblies and injection-molded or precision-machined components.
- Support design transfer from R&D to manufacturing, ensuring manufacturability and cost-effectiveness.
- Create process flow diagrams, work instructions, PFMEAs, and validation protocols (IQ/OQ/PQ).
- Collaborate with suppliers on injection molding, precision machining, and subassembly processes, including supplier qualification and capability assessment.
- Design and implement fixtures, tools, and test setups to support assembly and inspection.
- Conduct root cause analysis and implement corrective actions for process issues to improve yield, reliability, and throughput.
- Ensure all processes comply with ISO 13485, FDA 21 CFR Part 820, and internal quality system requirements.
- Contribute to documentation for regulatory submissions and manufacturing readiness.
Job Requirements
Qualifications:
- Bachelor's Degree required.
- 4 or more years' experience.
- Demonstrated success supporting new product introduction (NPI) and design transfer from R&D into pilot or full-scale production environments.
- Experience with the medical device development lifecycle, including risk management and design/process verification and validation.
- Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts.
- Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations.
- Proven project management and cross-functional collaboration skills.
- Excellent communication, problem-solving, and analytical abilities.
