- Entry level
- No Education
- Salary to negotiate
Heart Valve Engineer-181581
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.
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 evaluation processes associated 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
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
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.
Gore is a M/F, Disabled and Vet EEO/AA Employer. (Applies to all positions in the U.S.)
Keywords: Gore, job, Phoenix, Arizona, engineer, engineering, science, technical, technology, technologies, interventional, implantable, medical, devices, reliability, mechanical, chemical, materials, physics, manufacturing, products,
About the company
Gore is a materials science company whose associates are driven by curiosity and the opportunity to improve lives through our products and innovations.
Working closely and collaboratively with our customers, we devise best-fit solutions that work the first time and every time — delivering a high standard of reliability expected by our customers and the people they serve. With products ranging from medical devices that treat aneurysms to high-performance GORE-TEX® Fabrics, and with over 2,000 patents granted in our 55-plus-year history, we’re committed to innovations that improve lives.