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Engineer II, Biocompatibility
ICU Medical. We are seeking a Biocompatibility Engineer II to join our team.
About the role
Key responsibilities & impact- We are seeking a Biocompatibility Engineer II to join our team. As a member of the biocompatibility team, you will help ensure patient safety by contributing to the biological and toxicological evaluations of medical devices, materials, and processes. You will work closely with cross-functional teams to comply with global regulatory standards such as ISO 10993.
- You will leverage your understanding of the medical device biocompatibility field to provide guidance throughout the product development cycle, interpret regulatory requirements, and support the biocompatibility strategy. Using your analytical skills, you will review scientific data, identify gaps, and recommend risk mitigation strategies.
- This position will be pivotal in supporting regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with medical device regulations and standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, ISO 18562, and ISO 14971.
Requirements
What you’ll need- Must be at least 18 years of age.
- Bachelor’s degree in chemical or biomedical engineering, or related field, from an accredited college or university is required.
- 2+ years of Industry (Medical Devices) experience with a Bachelor.
- A Master's Degree or PhD in a relevant field may substitute for industry experience.
Benefits
Comp & perks- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biocompatibility evaluationtoxicological evaluationregulatory compliancerisk mitigation strategiesdata analysisproduct development cycledesign history file (DHF) remediation
Soft Skills
analytical skillscross-functional collaborationguidance provision
Certifications
Bachelor’s degreeMaster's DegreePhD