Senior Biocompatibility Engineer

Role details

Sr. Biocompatibility Engineer Confidential Search \| Medical Device

Confidential search for a global provider of advisory services for the healthcare industry, with a highly regarded clientele. Sr. Biocompatibility Engineer to lead biocompatibility assessments and biological evaluations for medical device products.

The Role

This is a senior scientific/advisory position, not a hands-on testing role - you'll operate at the assessment, strategy, and consulting level, partnering with clients, internal technical teams, and leadership to build defensible, regulator-ready assessments.

Key accountabilities:

• Lead development and authorship of biocompatibility assessments, biological evaluations, and risk assessments
• Perform and synthesise literature-based evaluations of materials, compounds, and device use
• Apply ISO 10993 principles and FDA expectations to support regulatory submissions
• Provide peer review and technical guidance on complex or high-risk projects
• Author opinion memos and other patient-safety-focused technical documentation
• Act as SME during client discussions and project initiation; communicate scientific/regulatory rationale to technical teams, clients, and senior stakeholders
• Support proposal development and scope review with project leadership
• Participate in international standards development
• Deliver technical presentations at conferences, seminars, and industry forums
• Contribute to continuous improvement of internal processes, templates, and best practices

What You'll Need

• Bachelor's degree in a relevant scientific discipline (Biology, Chemistry, Toxicology, Biomedical Engineering, Materials Science, Biotechnology, Pharmacology, or Engineering) with 7\+ years of relevant experience, OR an MS/PhD in a related field with 5\+ years of relevant experience
• Significant experience in biocompatibility assessment within a medical device environment
• Demonstrated expertise authoring assessments, evaluations, SOPs, and regulatory-facing documents
• Strong working knowledge of FDA-regulated environments and ISO 10993
• Exceptional technical writing and verbal communication skills, including comfort presenting to senior/executive audiences
• Proven ability to independently own projects and operate as a trusted expert