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:
In this role, you will manage and support a variety of projects within the commercialized product R&D engineering department. Key responsibilities include:
- 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
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