Nathalie Odryzynski

Director of Reliability Engineering @Medtronic

Minneapolis, MN, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2023 — Present

Director of Reliability Engineering @Medtronic

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MN, US

Leader of the Pre-Market Reliability Engineering Organization

EDUCATION

1994 — 1999

Mississippi State University

BS, Biological Engineering

1999 — 2001

University of Minnesota

MS, Biomedical Engineering

SKILLS

Iso 14971Regulatory AffairsMedical DevicesClinical ResearchCapaCardiologyVerification and Validation (V&V)V&VBiomedical EngineeringClinical TrialsPmaRegulatory RequirementsIso 13485Design ControlClinical DevelopmentFda

ABOUT NATHALIE ODRYZYNSKI

An experienced quality and reliability engineering leader with clinical research experience with a background in biomedical engineering.Over 7 years of people manager experience. 12+ years reliability/quality experience, which includes, leading teams in the following areas: risk assessments, trending and monitoring field performance data, assessing impact of non-conformances, manufacturing changes, design changes on device performance, test method validation, design verification and validation testing, root cause investigation, CAPA, audit support and manufacturing transfers. Extensive experience in working with the FDA and other international regulatory agencies. 10 years of experience designing and executing global medical device trials to meet business, regulatory and reimbursement needs (including PMA, IDE, FDA panel, post-market trials).

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Nathalie Odryzynski — Director of Reliability Engineering at Medtronic in Minneapolis, MN, US | Unifers