Pushkar Kulkarni
Research and Development Manager at Cook Medical
Based in Limerick, Ireland
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Seniority
Manager
Department
Research & Development
Location
Limerick
Industry
Medical Equipment Manufacturing
Company size
8.1K
Contact information
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p•••••••@cookmedical.com
Phone
5 credits+353 ••• •••• ••••
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Background
About Pushkar Kulkarni
Engineering professional with over 12+ years of experience; with particular expertise in Medical device industry. Responsible for post market engineering of medical devices. Engineering Lead for EU MDR 2017/745 Program. Technical expertise of EU MDR 2017/745 regulations. Knowledge of Pre-market notification (510k) Approval requirements. Successful submissions and approvals for EU MDR 2017/745 & Pre-market notification (510k) for various medical device families. Implementation of new product design for commercial use. Post market surveillance activities / reviews. Subject Matter Expert reviews of technical documentation. Expertise of ISO 13485, ISO 14971, ISO 11607, ISO IEC 62366, IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, 21 CFR Part 820 etc. Expertise in Medical device verification and validation Experience in risk management (DFMEA, UFMEA, RBA etc.) Knowledge on Statistical Analysis tool – Minitab. Experience in Creo 2.0/Pro-E Wildfire 5.
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