About this opportunity
Sitka Inc. lists this Senior Biocompatibility Scientist opportunity in flagstaff, Arizona. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Category: Engineering, Scientists & Technicians
Sub-Category: Science
Experience Level: Experienced
Work Arrangement: Hybrid
Posting Start Date: 9/23/26
Posting End Date: 10/8/26
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 and technology development, regulatory, and commercial product support teams to facilitate the process of medical device approval by global health authorities (e.g., US FDA, EU Notified Bodies, etc.).
This position will be located at our facility in Flagstaff or Phoenix, Arizona , with the possibility of a hybrid work arrangement.
Responsibilities
Developing biocompatibility evaluation plans for Gore medical devices or technologies in development or for changes to commercialized medical devices per ISO 10993-1 standards
Providing biological safety assessments for internal and external product/process/supply changes
Demonstrated ability to manage multiple medical device biocompatibility projects simultaneously, including timelines, budgets, risks, and stakeholder communications
Assisting 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
Receiving test reports from contract labs, reviewing for accuracy and acceptance criteria, working with the labs to address unexpected findings, and drafting Biocompatibility Evaluation
Reports summarizing test results for regulatory submissions
Helping project and regulatory teams prepare and generate documents in support of health authority “pre-submission” and submission activities for Gore medical devices as well as addressing agency questions regarding biocompatibility evaluations
Actively representing Gore on AAMI and/or ISO standards committees pertaining to medical device biocompatibility and assisting in standards management for biocompatibility standards
Required Qualifications
A Doctoral degree in biological sciences or related field (e.g., chemistry, biology, biomedical engineering) with a minimum of 3 years of experience in the medical device field; OR Master’s degree in biological sciences or related field with at least 5 years of experience in the medical device field
Evidence of active participation in AAMI and/or ISO standard working groups or committees pertaining to medical device biocompatibility
Strong understanding of ISO 10993 standards and hands-on experience in applying biocompatibility evaluation principles to global regulatory submission of medical devices
Self-motivated professional with strong communication skills, adept at collaborating effectively with technical, regulatory, and business stakeholders.
Ability to work effectively within and between teams in-person and in virtual settings
Demonstrated skills writing technical documents, preferably within a medical device quality system
Strong time management skills with proven experience in handling multiple projects, meeting deadlines, and managing diverse stakeholder expectations
A collaborative and self-motivated team player
Occasional travel (up to 10% of time) may be required
Desired Qualifications
Experience working with:
Contract research organizations (CROs)
Good Laboratory Practices (GLPs)
Critical Chain Project Management (CCPM)
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.
For over 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.
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. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Copyright 2025 W. L. Gore & Associates, Inc.
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Worksite address
flagstaff, AZ, 86004, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.