Senior Biocompatibility Scientist (Hybrid) - ISO 10993 Expert

wlgore; Flagstaff (AZ); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Gore Medical Products in Flagstaff or Phoenix, AZ, is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices by collaborating with product development, regulatory, and commercial teams to facilitate global health authority approvals.

This role emphasizes ISO 10993 expertise, active participation in standards groups, and the ability to manage multiple complex projects in a hybrid work environment.

Qualifications

• Doctoral degree with 3+ years medical device experience or Master’s with 5+ years.
• Active participation in AAMI and/or ISO standard groups or committees.
• Strong ISO 10993 knowledge and global regulatory submission experience.
• Excellent written and verbal communication with technical and regulatory stakeholders.
• Willingness to travel up to 10%.

Responsibilities

• Develop biocompatibility evaluation plans per ISO 10993-1 for devices in development or changes.
• Provide biological safety assessments for changes to products/processes.
• Manage multiple biocompatibility projects with timelines, budgets, risks, and stakeholders.
• Coordinate sample handling and shipping with contract testing labs.
• Review test reports and address findings to support submissions.
• Prepare documentation for health authority pre-submission and submissions.
• Represent Gore on AAMI and ISO committees related to biocompatibility.

Skills

Biocompatibility

Regulatory submissions

Project coordination

Cross-functional collaboration

Education

Doctoral degree in biological sciences or related field

Master’s degree in biological sciences or related field

Job description

Gore Medical Products in Flagstaff or Phoenix, AZ, is seeking a Senior Biocompatibility Scientist to ensure the biological safety of Gore medical devices by collaborating with product development, regulatory, and commercial teams to facilitate global health authority approvals.

This role emphasizes ISO 10993 expertise, active participation in standards groups, and the ability to manage multiple complex projects in a hybrid work environment.