Manager, Biocompatibility Engineering – R&D
ICU Medical
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Colorado, Connecticut, Maine, Montana, New York • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Direct and manage a team of engineers, scientists, and analysts to support new product development efforts and improvements to on-market devices.
- Oversee toxicologists for performing risk assessments and generating toxicology reports.
- Draft and author biocompatibility documentation (BEP, BER, Risk-Benefit analysis documentation.
- Participate in the design and planning of cleaning and disinfection validation protocols for the reprocessing of medical devices.
- Outline comparative analysis studies for the determination of biological, chemical, and physical equivalence.
- Function as the primary contact between ICU and third-party test houses (CRO), ensuring the accuracy and completeness of biocompatibility and chemistry testing.
- Serve as the primary liaison between ICU clinical teams and external consulting firms, translating experimental, clinical, and risk assessment needs into technical requirements and overseeing scope, timelines, and deliverables.
- Review and prepare reports for global regulatory submissions.
- Develop and execute strategic plans to maintain and improve internal and external analytical testing capability for meeting future regulatory and business needs.
- Actively participate in and review industry trends (via standards organizations, technical conferences, and focused review forums).
- Build and maintain strong relations with universities, outside contract research organizations, toxicologists, and consultants to conduct specialized testing and analysis as needed.
- Interact with senior management and others concerning matters of significance to the company and conduct technical briefings as needed.
- Write, review, and issue risk assessments, technical reports, peer reviewed publications, and similar documents for internal and external distribution.
- Create and foster an engaged and motivated working environment in the department through mentoring and coaching.
- Drive product innovation and process improvement within the department.
- Ensure compliance with ICU Medical quality policies and procedures.
Requirements
- Extensive knowledge and experience in biocompatibility assessment, testing, and risk evaluation for class II and III medical devices.
- Excellent documentation, communication, and interpersonal relationship skills including negotiation and relationship management with ability to drive achievement of objectives.
- Deep working knowledge within ISO 10993-1 and related standards.
- Working knowledge of ISO 18562
- Understanding of medical device reprocessing standards (ISO 17664:2017, AAMI ST98).
- Excellent understanding of global regulatory requirements related to medical devices biocompatibility and toxicology.
- Demonstrated capability of managing, leading, and developing direct reports.
- Experience with sample preparation, extraction, and separation techniques for polymer material analyses, analytical chemistry, and instrumentation analysis - e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS techniques.
- 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.
Benefits
- Competitive salary
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biocompatibility assessmentrisk evaluationsample preparationextraction techniquesseparation techniquesanalytical chemistryFTIRHPLCGCICP-MS
Soft skills
documentation skillscommunication skillsinterpersonal skillsnegotiation skillsrelationship managementleadershipmentoringcoachingtechnical briefingprocess improvement