Director, Biocompatibility Engineering R&D

Job Description

Position Summary

The Director of Biocompatibility Engineering will lead the centralized development, implementation, and oversight of biocompatibility programs for ICU Medical's global medical devices. The role will be responsible for overseeing the biocompatibility assessment and testing for all new and existing products.

This individual will ensure that all products meet regulatory standards and guidelines related to biological safety and compatibility, particularly the EU Medical Device Regulations (EU MDR), FDA, and ISO 10993 series. The ideal candidate will have expertise in toxicology, materials science, and regulatory affairs, and will work cross-functionally with R&D, quality assurance, regulatory, and manufacturing teams.

Essential Duties & Responsibilities

• Lead team in the design, implementation, and management of biocompatibility testing strategies and protocols for all products, ensuring compliance with global regulatory standards (ISO 10993, FDA, EU, etc.) across multiple divisions of ICU Medical.
• Manage biocompatibility risk assessments, including biological evaluation of materials, testing for cytotoxicity, irritation, sensitization, and systemic toxicity.
• Collaborate with R&D and product development teams to provide guidance on material selection, biological performance, and safety throughout the product lifecycle.
• Oversee the preparation and submission of biocompatibility documentation required for regulatory approvals, including reports for FDA 510(k), PMA, CE marking, and other relevant regulatory filings.
• Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance.
• Develop and execute strategic plans to maintain and improve internal and external analytical testing capability for meeting future regulatory and business needs.
• Develop and maintain strong relationships with external testing labs, regulatory bodies, and industry stakeholders to ensure timely completion of biocompatibility evaluations and actively participate in and review industry trends.
• Manage budgets and timelines for biocompatibility studies, ensuring alignment with overall project goals.
• Prepare and deliver presentations to senior management and stakeholders on biocompatibility-related risks, progress, and regulatory strategies.
• Create and foster an engaged and motivated working environment in the department through mentoring and coaching.
• Ensure compliance with ICU Medical quality policies and procedures.
• Work on special assignments as they arise

Knowledge, Skills & Qualifications

• Extensive knowledge and experience in biocompatibility assessment, testing, and risk evaluation for class II or III medical devices.
• Excellent documentation, communication, and interpersonal relationship skills including negotiation and relationship management with ability to drive achievement of objectives.
• Deep understanding of ISO 10993, FDA guidelines, EU regulations, and other international biocompatibility standards.
• Proven experience in biocompatibility testing, including cytotoxicity, irritation, sensitization, systemic toxicity, and material characterization.
• Demonstrated capability of managing, leading, and developing direct reports.
• Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines, and writing technical reports, toxicological risk assessments, and biocompatibility evaluations.
• Able to work quickly and effectively in a fast-paced, dynamic work environment.
• Proficient in the use Microsoft Office tools - Word, Office, Power Point, and Outlook

Education and Experience

• Master's degree in Science or Engineering (Chemistry or Materials/Polymers) from an accredited college or university; PhD is preferred
• Minimum 7-15 years of relevant experience in the medical device industry or combination of medical device and pharmaceutical/biotechnology

Travel Requirements

• Typically requires travel less than 5 % of the time

Physical Requirements and Work Environment

• This is a mix office and laboratory role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Must be able to occasionally move and lift objects of up to 25 lbs

Salary Range - $150,000 - $205,000

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.

About Us

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.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and 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 identity, gender expression, gender reassignment, 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 humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants