Visceral Global Product Specialist

We are seeking a Global Product Specialist (GPS) to join our Aortic team in the Visceral Category.  In this role, you will be responsible for successfully supporting commercial use of Gore Visceral products and supporting new product development in the visceral space by providing clinician and market insights. As part of the team, you will work closely with team members from various disciplines, including marketing, sales, engineering, manufacturing, biological sciences, clinical medicine, regulatory, clinical affairs, health economics, legal, and business. You will also engage with healthcare providers, including global key opinion leaders and physicians, to gain insights into clinical user needs to ensure product success.

This position will be located at one of our facilities in Flagstaff or Phoenix, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• Ensure device development success throughout the product lifecycle, including defining safety and effectiveness requirements in diverse applications for internal teams
• Accountable for business decisions related to product success
• Ensure clinical and technical accuracy of external communications (marketing materials, regulatory submissions, etc.)
• Interface with external clinical customers on product usage, therapeutic needs, and clinical research activities 
• Apply understanding of clinical needs, procedures, and product use to navigate  technical, clinical and regulatory plans
• Ensure timely investigation, resolution, and communication of product performance and use issues
• Support manufacturing operations to ensure product quality while promoting efficiency and product supply
• Develop and apply deep knowledge of disease state and product clinical use to inform technical requirements for NPD (user needs, design inputs, and testing conditions)

Required Qualifications

• Doctorate degree in engineering, science or medicine OR Bachelor’s degree in engineering, science, nursing or marketing PLUS one of the following: A minimum of 4 years of product management or marketing experience in the medical device or pharmaceutical industry
• Direct experience supporting commercial or new product development of visceral (juxtarenal, pararenal, thoracoabdominal) complex aortic device
• Experience effectively and successfully interacting with and influencing multiple internal functions (including technical, manufacturing, regulatory, legal, sales, product specialists and marketing) as well as external partners (e.g., physicians)
• Demonstrated experience managing multiple projects and priorities simultaneously and in ambiguous situations
• Familiar with medical industry regulations in major global markets
• Strategic thinker with demonstrated ability to resolve complex, multi-dimensional problems
• Excellent written and verbal communication and presentation skills
• Ability to read, interpret, and communicate scientific or clinical publications and data 
• Ability to travel extensively, up to 30% on average, up to 40% at peak times, including international travel 

Desired Qualifications

• Experience working on New Product Development projects
• Experience supporting complex visceral aortic clinical studies
• Experience supporting a custom made or patient specific medical device

This role requires ongoing access to U.S. hospitals and compliance with facility-specific access policies (which may include a requirement to provide proof that you are fully vaccinated with one of the COVID-19 vaccines), vendor credentialing requirements including drug screening, background checks, immunization and training.

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.