Senior Biocompatibility Engineer

Metric Geo; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Metric Geo is seeking a Sr. Biocompatibility Engineer to lead biocompatibility assessments and regulatory evaluations for medical device products.

This advisory role operates at strategy and client-facing levels, partnering with clients and internal teams to develop defensible, regulator-ready assessments. The role emphasizes authoring SOPs and technical memos, applying ISO 10993 and FDA expectations, and presenting findings to senior stakeholders.

Qualifications

• Bachelor's degree with 7+ years of relevant experience or MS/PhD with 5+ years
• Significant experience in biocompatibility assessment within a medical device environment
• Demonstrated expertise authoring assessments, evaluations, SOPs, regulatory-facing documents
• Strong working knowledge of FDA-regulated environments and ISO 10993
• Exceptional technical writing and verbal communication skills with senior audiences

Responsibilities

• Lead development and authorship of biocompatibility assessments, biological evaluations, and risk assessments
• Perform and synthesize 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 rationale to teams and stakeholders
• Support proposal development and scope review with project leadership
• Deliver technical presentations at conferences, seminars, and industry forums
• Contribute to continuous improvement of internal processes, templates, and best practices

Skills

Biocompatibility assessment

Regulatory writing

FDA/ISO10993 knowledge

Project leadership

Stakeholder communication

Education

Bachelor's degree in Biology/Chemistry/Engineering

MS/PhD in related field

Job description

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
• 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