Senior Biocompatibility Scientist

Sitka Inc.; Flagstaff (AZ); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Gore is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices by interfacing with product development, regulatory, and commercial teams to facilitate FDA and global approvals.

The role can be located at Gore’s facility in Flagstaff, AZ or Phoenix, AZ with a hybrid work arrangement. The candidate will contribute to biocompatibility strategies and regulatory readiness across multiple projects.

Qualifications

• Doctoral degree in biological sciences or related field with a minimum of 3 years in medical devices, or Master’s with at least 5 years in medical devices.
• Active participation in AAMI and/or ISO standard working groups or committees for medical device biocompatibility.
• Strong understanding of ISO 10993 and hands-on regulatory submission experience.
• Excellent written and verbal communication skills and ability to collaborate with regulatory, technical and business stakeholders.

Responsibilities

• Develop biocompatibility evaluation plans per ISO 10993-1 for devices in development or changes to commercial devices.
• Provide biological safety assessments for product/process changes.
• Manage multiple biocompatibility projects with timelines, budgets, risks, and stakeholders.
• Coordinate sample testing with contract labs and oversee test reports and acceptance criteria.
• Assist in preparing regulatory submissions and respond to agency questions on biocompatibility.

Skills

Biocompatibility expertise

Regulatory collaboration

Project management

Scientific writing

Cross-functional teamwork

Education

PhD in biological sciences

Master's in biological sciences

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.