Staff Biocompatibility Scientist

Staff Biocompatibility Scientist

As a Staff Biocompatibility Scientist, you will play a pivotal role in safeguarding patient health by leading biocompatibility initiatives for medical devices, materials, and processes. Acting as a Subject Matter Expert (SME) within the Global Biocompatibility Group, you will collaborate with cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements, such as ISO 10993.

You will apply your deep expertise in biocompatibility throughout the product lifecycle, supporting Class II and III medical devices. This includes interpreting regulatory requirements, guiding strategy development, and critically evaluating scientific data to identify risks and recommend mitigation strategies.

Key Responsibilities:

• Author, review, and approve biocompatibility assessments, evaluation plans, and reports in alignment with ISO 10993 and FDA guidance.

• Partner with cross-functional teams to support multiple projects, ensuring timely and compliant biocompatibility deliverables.

• Analyze test results for biological effects, troubleshoot anomalies, and provide technical guidance. Evaluate research findings and recommend future research directions.

• Support global regulatory submissions by articulating biocompatibility strategies and responding to agency inquiries (e.g. FDA, PMDA, EU and NMPA).

• Stay current with evolving biological safety standards and regulations, and conduct gap analyses to identify and mitigate potential product and business risks.

Required Qualifications:

• Bachelors Degree (± 16 years), B. S in biological or physical sciences, or mathematics; with 10 + years of progressively responsible positions in a research development environment OR Doctorate Degree (± 19 years), PhD with 4 years of experience

• Minimum 4 years with PhD- Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience. Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpreting data. Application/understanding of regulations and standards affecting IVDs and Biologics. Able to provide implementation of regulations into the technical decisions. Basic computer skills - able to learn new computer programs

• Minimum 10 years with BA/BS - Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience. Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpreting data. Application/understanding of regulations and standards affecting IVDs and Biologics. Able to provide implementation of regulations into the technical decisions. Basic computer skills - able to learn new computer programs

Preferred Qualifications:

• Ph.D. with a minimum of 5 years, or master’s degree with minimum of 7 years or bachelor’s degree* with minimum of 10 years of industry experience in medical devices, pharmaceuticals, or biotechnology, with a focus on biocompatibility or biological safety assessments.

• Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive) and Adobe pdf.

• In-depth knowledge of ISO 10993, biomaterials, toxicological risk assessment, extractables and leachables, biocompatibility methodologies, and medical device manufacturing processes.

• Bachelor’s degree in one or more of the following or related disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) preferred although comparable areas of study and industry experience is considered for the position.

• Demonstrated ability to draw conclusions, present and make recommendations based on technical inputs from multiple and varied functions

• Ability to leverage and/or engage others to accomplish project deliverables.

• Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit

• Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables