Senior Biocompatibility Scientist

Role details

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)
• Medical device product development in a corporate environment
• 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.