About the Role

We are seeking a Global Product Specialist (GPS) to join our Surgical Solutions business.  In this role, you will be responsible for ensuring fitness for use (FFU) for commercial products.  As part of the team, you will work closely with team members from various disciplines, including marketing, sales, engineering, manufacturing, biological sciences, 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 fitness for use for Gore’s products.  

This is fully remote position and can work from most locations within the United States.

Responsibilities

• Ensure device fitness for use (FFU) throughout the product lifecycle, including defining safety and efficacy requirements in diverse applications  
• Accountable for waterline decisions related to FFU 
• Interface with external clinical customers on product usage, therapeutic needs, and clinical research activities  
• Propose, evaluate, and execute product lifecycle management activities related to SKU rationalization, launch, and discontinuation
• Apply understanding of clinical needs, procedures, and product FFU to navigate events, risks, benefits, testing, clinical and regulatory plans 
• Represent product-level activities in business processes including business reviews, operational planning, and marketing planning
• Utilize Gore Business System processes to manage project timelines and implement the problem solving process when needed
• Support manufacturing operations to ensure product quality while promoting efficiency and product supply 
• Ensure timely investigation, resolution, and communication of product performance and use issues
• Ensure clinical and technical accuracy of external communications (marketing materials, regulatory submissions, etc.) 

Required Qualifications

• Doctorate degree in engineering, science or medicine OR Bachelor’s degree in engineering or science (or equivalent professional experience) PLUS one of the following: A minimum of two (2) years’ experience as a Product Specialist (PS) or Clinical Application Specialist (CAS) OR a minimum of 4 years of product, project or technical leadership experience in medical device industry
• Demonstrated experience managing multiple projects and priorities simultaneously and in ambiguous situations
• 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)
• Strategic thinker with demonstrated ability to resolve complex, multi-dimensional problems
• Proactive work style, working both independently and as part of a team
• Ability to read, interpret, and communicate scientific or clinical publications and data  
• Excellent written and verbal communication and presentation skills
• Ability to travel extensively, up to 25% on average, up to 40% at peak times, including international travel

Desired Qualifications

• Prior CAS or PS experience working with Surgical implantable medical products
• Experience providing cross-regional commercial support

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.