R&D Engineer

Location: Irvine, CA

Schedule: Standard

Duration: 12 Month Contract

Pay Range: $38.50-43.50/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.

Job Responsibilities: 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 Essential Job Duties and Job Functions 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

Knowledge and Skills: 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

Education and Experience: 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