Job Details

ID #44716673
State California
City Irvine
Job type Contract
Salary USD competitive competitive
Source Real Staffing
Showed 2022-08-09
Date 2022-08-09
Deadline 2022-10-08
Category Et cetera
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Senior R&D Engineer

California, Irvine, 92602 Irvine USA

Vacancy expired!

Title: Sr. R&D Engineer

Job Type: 10 month contract (no conversion but possibility to extend)

Location: Irvine, CA

Duties: The Senior R&D Engineer will play a key role in support of Edwards 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.

Essential Job functions include:

  • 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

Qualifications:
  • Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred
  • Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
  • Experience utilizing statistical techniques to support design decisions and product acceptance testing
  • Previous experience working with lab/industrial equipment required (if applicable)
  • Experience with design controls, design verification & validation, or design test method development
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work ability to influence change
  • Knowledge of applicable FDA regulations for medical device industry Strict attention to detail
  • Bachelor's Degree in Engineering with, 3+ years experience including either industry or industry/education required or Master's Degree 2+ years experience including either industry or industry/education

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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