Description

• Develop strategies to improve biocompatibility/microbiology test cycle times.
• Author test protocols and identify gaps in current R&D compatibility testing for new and existing products.
• Create biocompatibility microbiology project plan and testing activities around testing for new product submission to regulatory bodies
• Communicate and coordinate with both internal departments such as development, regulatory, quality, clinical, and manufacturing, as well as external resources such as Contract Research Organizations (CROs), to devise test strategies and ensure proper implementation of necessary testing in accordance with internal standard operating procedures (SOPs), recognized standards, and applicable global regulatory requirements (e.g., FDA, ISO).
• Direct testing activities with current and new suppliers; identify 2nd source suppliers for biocompatibility testing of new products.
• Collaborate with cross-functional teams including manufacturing, packaging, quality engineering, production, regulatory, and other departments to facilitate biocompatibility activities
• Demonstrated aptitude for identifying and resolving problems, implementing effective solutions, and leading initiatives to promote ongoing improvement.
• Evaluate the biocompatibility test outcomes to ascertain whether the data sufficiently meets the criteria for biological effects and employ technical expertise and analytical skills to address any unforeseen results.
• Assist in addressing regulatory inquiries pertaining to past biocompatibility reports in order to facilitate domestic and international registrations
• Other duties as assigned.

• Bachelor’s degree in Biochemistry, Chemistry, Engineering, or Scientific/Quality related field.
• Minimum 8-10+ years of experience in medical device or related industry.
• Experience reading and preparing technical documentation.
• Outstanding communication skills, both verbal and written.
• Ability to work collaboratively within a dynamic team environment.
• Self-directed; must be able to meet project goals with minimal supervision.
• Excellent computer skills including Word, PowerPoint, and Excel.
• Familiarity with FDA and ISO regulations

For United States Applicants Only:
Inari Medical E-Verify Poster (English and Spanish)
Inari Medical Right to Work Poster (English)
Inari Medical Right to Work Poster (Spanish)