Senior Engineer, Biocompatibility

ICU Medical•Dublin, OH

About The Position

The Senior Biocompatibility Engineer will play a critical role in ensuring patient safety by overseeing biocompatibility evaluations of medical devices, materials, and processes. This position will collaborate with cross-functional teams to ensure compliance with global regulatory requirements such as ISO 10993. Utilizing expertise in the medical device biocompatibility field to provide guidance throughout the product lifecycle, interpreting regulatory requirements and supporting the biocompatibility strategy team. This position will use analytical skills to review scientific data and assess any gaps, while also making recommendations to mitigate risks.

Requirements

Must be at least 18 years of age
Bachelor’s degree in biology, biochemistry, toxicology, pharmaceutical science, pharmacology analytical chemistry or materials science from an accredited college or university is required
Minimum 7 years of Industry (medical device) experience required
Proficiency in MS Office and strong written and verbal communication skills
Ability to work within a fast-paced, changing environment, prioritize tasks, and meet deadlines
Strong organizational and follow-up skills, attention to detail, and experience working in a cross-division business unit

Responsibilities

Material Compliance & Restricted Substances: Lead and manage EU MDR-related DHF remediation activities with a focus on legacy material compliance and regulatory gap assessments.
Author verification and validation (V&V) reports specifically addressing restricted substance evaluations in accordance with global regulatory requirements.
Act as the primary contact for supplier declarations of conformity, ensuring documentation aligns with material compliance standards and supports international regulatory filings.
Develop and maintain a comprehensive database of raw materials, capturing compliance attributes across multiple global markets.
Support the Regulatory and Biological Safety teams by performing chemical characterization analysis per ISO 10993, 18562, and EU MDR requirements.
Draft/author reprocessing testing procedures for reusable medical devices
Conduct performance gap assessments related to restricted substances in V&V protocols, production results, lab data, and biocompatibility studies.
Review and contribute to Biological Evaluation Reports (BERs), ensuring alignment with ISO 10993 and restricted substance regulations.
Assist with cross-functional documentation updates, including Traceability Matrices, Article 18 content, and regulatory Dossiers.
Cross-Functional Leadership & Project Execution: Drive cross-functional collaboration with Procurement, R&D, Program Management, QA, and Biocompatibility Engineering to ensure cohesive regulatory alignment.
Lead SME review meetings to drive label assignment initiatives and meet compliance timelines.
Provide regular updates on program progress to the Biocompatibility Manager and Director of Regulatory Affairs.
Take ownership of challenging project deliverables, ensuring high-quality and timely execution in fast-paced environments.
Post-Market & Risk Management: Analyze end-user interface feedback related to material performance and usability risks.
Review risk documentation (e.g., ISO 14971 risk assessments, pFMEA, RMR) with emphasis on material hazards and restricted substances.