Position Summary
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.
Essential Duties & 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.
Knowledge & Skills
- 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
Minimum Qualifications, Education & Experience
- 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
Work Environment
- 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
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.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:
- 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.
This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.
ICU Medical EEO Statement:
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates.