Development Engineering

R&D Engineer

Duration: 12 Month Contract

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

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

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

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

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

Strong experience in quality engineering, R&D, or manufacturing engineering preferred

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