Senior Biocompatibility Scientist
About the Role: We are looking for a Senior Biocompatibility Scientist to join our team. In this role, you will help assure the biological safety of Gore medical devices by interfacing with product development, regulatory, and commercial product support teams to facilitate the process of medical device approval by health authorities (e.g., US FDA, EU Notified Bodies, etc.).
This position offers multiple work arrangements: on-site at our facility in Flagstaff, Arizona or Phoenix, Arizona, hybrid or fully remote work allowed in most locations within the United States, depending upon the responsibilities of the role and business needs.
Responsibilities:
- Develop biocompatibility evaluation plans for new Gore medical devices or changes to existing medical devices per ISO 10993-1 standards
- Assist product teams in preparation, ordering and shipping of test samples to contract testing labs including managing communications with the contract labs during the testing process
Required Qualifications:
- A Doctoral degree in biological sciences or related field (e.g., chemistry, biology, biomedical engineering) with a minimum of 3 years industry or related experience OR Master’s degree in biological sciences or related field with a minimum of 4 years experience in a medical device or related field OR Bachelor’s degree in biological sciences or related field with a minimum of 7 years experience in a medical device or related field
- Strong understanding of ISO 10993 standards and hands-on experience in applying biocompatibility evaluation principles to medical devices
- Self-motivated professional with strong communication skills, adept at collaborating effectively with technical, regulatory, and business stakeholders
- Excellent verbal and written communication skills
- Strong time management skills with proven experience in handling multiple projects, meeting deadlines, and managing diverse stakeholder expectations
- Collaborative and self-motivated team player
- Ability to work effectively within and between teams in remote or virtual settings
Desired Qualifications:
- A Doctoral degree in biological sciences or related field with a minimum of 3 years experience Master’s degree in biological sciences or related field with a minimum of 4 years experience
- Experience working with contract research organizations (CRO’s), Good Laboratory Practices (GLPs), medical device product development, writing technical documents, preferably within a medical device quality system
- Participation in AAMI and/or ISO standard working groups or committees
Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
About Gore
For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.