R&D Engineer II

TalentBurst•Irvine, CA

3d•Onsite

About The Position

The E2 R&D Engineer will play a key role in support of the client transcatheter aortic valve therapies. This role is responsible for leading and supporting key projects associated with our commercialized THV products. This includes support of product configuration changes, providing design control expertise for supply-chain driven manufacturing improvements, leading investigations into field performance issues and support of product labeling and training updates associated with our global therapy expansion.

Requirements

Bachelor's Degree required in an engineering or scientific field, plus (4) years of experience in quality engineering; OR Master’s Degree in engineering or scientific field, with (3) years of experience in quality engineering
Lifesciences industry experience (i.e. medical device, pharma, or biotech)
Experience with design controls, design verification & validation, or design test method development
Demonstrated experience reviewing and updating risk management related documents
Experience utilizing statistical techniques to support design decisions and product acceptance testing
Effective communication, listening, and diagnostic skills, verbal and written, are necessary.
The demonstration of effective collaboration and influencing skills will be key so that the candidate can achieve results within the cross-functional team and with stakeholders around the company.
Ability to work well independently and as a member of a team is essential.

Nice To Haves

Master's Degree in an engineering, scientific or a related discipline
Medical device industry experience highly preferred.
Experience in catheter-based therapies preferred.
Design control and design change experience for product improvements
Experience with sustaining activities for commercialized products
Strong experience in quality engineering, R&D or manufacturing engineering
Design for Six Sigma or Lean Six Sigma Certification (Green belt or black belt)
Working knowledge and understanding of statistical techniques
Previous experience working with test lab equipment required (if applicable)
Strong problem-solving, organizational, analytical and critical thinking skills
Good leadership skills and ability to influence change
Knowledge of Design Control
Knowledge of applicable FDA regulations for medical device industry desirable
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Experience in new product development with successful design experience from concept to commercialization is strongly preferred.

Responsibilities

Provide Engineering input to THV commercialized product projects including application of design control and risk management
Develop solutions to a variety or problems of moderate scope and complexity.
Be a subject matter expert on field performance of THV devices and the design features associated with key performance metrics
Apply mechanical and biomedical engineering principles to the design and development of components for the delivery system and accessories.
Adaptable to broad scope of projects including material changes, manufacturing improvements, packaging and labeling changes, use instruction and usability changes.
Develop test methods and procedures to evaluate device prototype performance.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Build partnerships with key cross functional stakeholders
Maintain accurate documentation of concepts, designs, drawings, and procedures.
Generate written protocols, reports, and technical justifications/summaries.
Other incidental duties assigned by Leadership