Ian Manion
Senior Biocompatibility Engineer @Medical Components, Inc
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WORK HISTORY
Senior Biocompatibility Engineer @Medical Components, Inc
Works to prove biological safety of prolonged and long-term patient blood contacting medical devices, including infusion and hemodialysis catheters- Uses ISO 10993 to author biological safety evaluation plans assessing the biological risk and patient safety of currently marketed medical devices to support EU MDR remediation- Responds to regulatory and notified body deficiency questions- Uses an individualized strategy for each product to update existing BSEs to current EU MDR regulations- Assesses supplier information, manufacturing process steps, manufacturing process contaminants, biological testing results, and device raw materials for potential impacts to biological safety- Works closely with cross functional groups (including R&D, Supplier Quality and Sourcing, Clinical Affairs, Regulatory Affairs, and Manufacturing) to meet shared deadlines- Coordinates with outside organizations to perform biological and chemical characterization testing to satisfy biological endpoints or to address gaps in existing documentation
EDUCATION
College of Saint Benedict and Saint John's University
Bachelor of Arts (B.A.), Chemistry
Southwest University
Certificate of Completion, Modern Chinese Course (Elementary Level 1), Comprehensive: 96/100, Speaking/Listening: 92/100, Reading/Writing: 90/100
ABOUT IAN MANION
Scientist in the medical device industry. Currently working as a biocompatibility scientist conducting biological safety evaluations for current dialysis implants and accessories to assess biological risk to patients in support of EU MDR remediation efforts. Experienced with working with a variety of analytical instrumentation including GC, HPLC, and FTIR in a high throughput GMP environment. Experienced with medical device extractions and testing per ISO 10•••12 and ISO 10•••18 guidelines. Has experience developing, writing and performing test method and validation protocols and writing SOPs. Has an enthusiastic and outgoing personality, easy to work with, enjoys solving problems, and detail and process oriented. Performs well working solo as well as with a team in high throughput environments with frequently changing and aggressive timelines.
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