Michelle Chutka Email & Phone Number

Nearly 20 years of experience in medical devices at Cook Biotech Incorporated, most recently serving as Director of Product Engineering from January 2016 to September 2024.Activities include:- Leadership and oversight for three (3) distinct product development engineering units, ranging from early stage feasibility through product lifecycle engineering/sustaining engineering.- Product development portfolio management and financial analysis of new ventures- Design Control 21 CFR 820- Risk Management ISO 14971:2019- Quality System ISO 13485:2016- Animal tissues in Medical Devices EN ISO 22442- FDA and International Regulatory submission support, assessment and preparation (EU-MDR/APAC)- Design and planning non-clinical studies (feasibility/bench testing, V&V testing, animal studies)- Clinical assessment via feedback from physicians- Process Validation and Process Development/Scale-UpI strive to create opportunities where professionals collaborate on challenging technical issues and work together to build a company culture of continuous improvement.Specialties: Design Control, Risk Management, Project Management, Lean Manufacturing, Process validations and development, ISO 11607, ISO 11137, Tissue Engineering

Listed skills include Fda, Iso 13485, Medical Devices, Quality System, and 12 others.

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  Continuing Lecturer

  Purdue University

  West Lafayette, In, Us