R&D Engineer

R&D Engineer

Location: Irvine, CA
Schedule: Standard
Duration: 12 Month Contract
Pay Range: $/hr

Our client, a leading medical device company, is seeking an R&D Engineer to support its transcatheter aortic valve therapies. This role leads and supports key projects for commercialized THV products, including product configuration changes, design control support for supply-chain driven manufacturing improvements, investigations into field performance issues, and labeling and training updates tied to global therapy expansion.

• Providing engineering input to commercialized THV product projects, including application of design control and risk management
• Developing solutions to problems of moderate scope and complexity
• Serving as a subject matter expert on field performance of THV devices and the design features tied to key performance metrics
• Supporting product configuration changes, supply-chain driven manufacturing improvements, field performance investigations, and labeling and training updates

• Apply mechanical and biomedical engineering principles to the design and development of delivery system components and accessories
• Work across a broad scope of projects, including material changes, manufacturing improvements, packaging and labeling changes, and instructions for use and usability changes
• Develop test methods and procedures to evaluate device prototype performance
• Assign support tasks, give instruction to technicians on conducting tests, train technicians and provide feedback, and coordinate technician work as needed
• Build partnerships with key cross-functional stakeholders
• Maintain accurate documentation of concepts, designs, drawings, and procedures
• Generate written protocols, reports, and technical justifications/summaries
• Perform other incidental duties assigned by leadership

• Experience with design controls, design verification and validation, or design test method development
• Demonstrated experience reviewing and updating risk management documents
• Experience using statistical techniques to support design decisions and product acceptance testing
• Effective verbal and written communication, listening, and diagnostic skills
• Collaboration and influencing skills to achieve results with cross-functional teams and stakeholders
• Ability to work independently and as part of a team, including inter-departmental teams, and to act as key contact representing the organization on contracts or projects
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Good leadership skills and ability to influence change
• Knowledge of design control and design change for product improvements
• Experience with sustaining activities for commercialized products
• Working knowledge of statistical techniques
• Experience with test lab equipment (if applicable)
• Knowledge of applicable FDA regulations for the medical device industry desirable
• Design for Six Sigma or Lean Six Sigma certification (Green Belt or Black Belt) preferred

• Bachelor's degree in an engineering or scientific field plus 4 years of quality engineering experience, OR Master's degree in an engineering or scientific field plus 3 years of quality engineering experience
• Life sciences industry experience (medical device, pharma, or biotech)
• Experience in new product development, with successful design experience from concept to commercialization, strongly preferred
• Master's degree in engineering, science, or a related discipline preferred
• Medical device industry experience highly preferred
• Catheter-based therapy experience preferred
• Strong experience in quality engineering, R&D, or manufacturing engineering preferred