[Hiring] Senior Engineer, Biocompatibility @ICU Medical

Role Description

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.

• Utilize expertise in the medical device biocompatibility field to provide guidance throughout the product lifecycle.
• Interpret regulatory requirements and support the biocompatibility strategy team.
• Review scientific data and assess any gaps, making recommendations to mitigate risks.

Qualifications

• 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.
• 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.

Requirements

• 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.
• 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.
• 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.

Benefits

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time.
• Expected to be able to complete tasks with minimal supervision.

Company Description

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.