Heart Valve Engineer

WL Gore Medical Products Division   •  

Phoenix, AZ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 69 days ago

This job is no longer available.

Description

Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Our diverse portfolio includes everything from high-performance fabrics and implantable medical devices to industrial manufacturing components and aerospace electronics. Through our product leadership, we've been changing lives and changing industries for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.

Job Description

Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 35 years, saving and improving the quality of lives worldwide. As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for an engineer with strong Heart Valve (HV) technical expertise and experience to lead and organize engineers for valve products in compliance with established and accepted industry standards and practices. This individual will be experienced and knowledgeable of the FDA and ISO standard related to performance requirements, design inputs, risk assessment and evaluationprocessesassociated with heart valve development programs.

If you are searching for a company where you can make a difference, we’re looking for you to join our team in Phoenix, AZ.

The ideal candidate will be:

  • Passionate about providing engineering support for state-of-the art implantable medical devices
  • Energized by working for a world-class manufacturer and collaborating on cross-functional teams
  • Comfortable with working on programs with aggressive timelines and high visibility across the division
  • Adaptable to changing organizational structures
  • Able to build and maintain strong interpersonal relationships

Responsibilities include:

  • Working closely with the HV Business Unit and providing detailed technical input and guidance to development teams
  • Working with teams to ensure appropriate design quality assessment including all stages of design control, usability, risk assessment, and commercial launch
  • Organizing and providing expertise to development teams around functional and performance requirements and technical support of regulatory submissions for all heart valve programs to ensure consistency in methods/approaches and submission content
  • Providing interpretation and guidance regarding ISO 5840 and FDA HV Guidance document requirements
  • Transitioning new products into manufacturing and supporting existing manufacturing, including the transition of these operations from various geographic locations in the Medical Products Division
  • Selecting, evaluating, and validating components from various potential supply sources
  • Designing, executing, and analyzing experiments based on statistical techniques
  • Gaining a fundamental understanding of device use, development of visual standards, and general manufacturing troubleshooting
  • Develop, maintain, and execute R&D project plans and coordinate cross functional team developmental activities in support of company's strategic plan
  • Interaction with Key Opinion Leaders (KOLs) to determine their needs/wants and translate into design inputs

Qualifications

Required Job Qualifications:

  • Minimum of a bachelor's degree in a technical field
  • Greater than 5 years’ experience in the heart valve industry as an engineer
  • Experience in medical device design control regulations
  • Excellent written and verbal communication skills
  • Experience working in cross functional teams and in an independent contributor role
  • Advanced problem-solving, organizational, analytical, and critical thinking skills
  • A work style of hands-on involvement with all phases of projects
  • Demonstrated ability to prioritize, initiate, and drive projects to completion

Desired Job Qualifications

  • Advanced technical degree

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

Gore requires all applicants to be eligible to work within the US. Gore generally will not sponsor visas unless otherwise noted on the position description.

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