Global Product Specialist

About the Role

We are seeking a Global Product Specialist (GPS) with prior experience leading large-scale early stage New Product Development Projects (NPD) to join our Peripheral team. While this position will be primarily responsible for advancing early-stage NPD projects through the development funnel, the role may also provide some general support to the wider peripheral GPS team as required. The ideal candidate will have experience partnering externally with Key Opinion Leaders and internally across functions to effectively move projects through the development life cycle. As part of the team, you will work closely with external customers and internal team members from various disciplines, including marketing, sales, engineering, manufacturing, biological sciences, clinical medicine, regulatory, clinical affairs, health economics, legal, and business. 

 

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

Responsibilities

• Navigate the New Product Development Stage Gate process in partnership with the project cross functional leadership team
• Utilize Gore Business System processes to manage project timelines and implement the problem solving process when needed
• Work with external vendors to accelerate project timelines
• Develop product positioning and go-to-market strategies in partnership with the Global Brand Manager
• Ensure device Fitness for Use throughout the product lifecycle, including defining safety and efficacy requirements in diverse applications
• 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 fitness for use to navigate events, risks, benefits, testing, 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

 

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: minimum of two (2) years’ experience as a Product Specialist 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, contract research and development organizations, contract manufacturing, etc.)
• Proactive work style, working both independently and as part of a team
• Excellent written and verbal communication and presentation skills
• Strategic thinker with demonstrated ability to resolve complex, multi-dimensional problems
• Ability to read, interpret, and communicate scientific or clinical publications and data
• Ability to travel extensively, up to 25% on average, up to 40% at peak times, including international travel

 

Desired Qualifications

• Prior Product Specialist experience working on large-scale New Product Development projects
• Experience working in the Peripheral Arterial Disease space
• Experience with combination products 

 

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.