KRISHANU DAS

acy63f@r.postjobfree.com 813-***-**** / 574-***-****

*** ********** **. ****** ** 46580

Manufacturing Engineer with process validation and project management capability. Efficient collaborator who moves projects forward in a competent & technically sound manner. Hands on experience in designing and executing validations for key processes. EDUCATION

Masters of Science in Biomedical Engineering (08/2013 – 05/2015) University of South Florida, Tampa, Florida GPA - 3.46 Recipient of Graduate Assistantship

Bachelor of Engineering in Biomedical Engineering (08/2008-05/2012) University of Mumbai, Mumbai, India

WORK EXPERIENCE

Manufacturing Engineer at Zimmer Biomet (02/2016 – Present)

• Responsible for process validation of various implants passing through Ultrasonic Cleaning Lines.

• Experience working on the Action Plan and Implementations phase of multiple CAPA projects.

• Successfully handled a $1M insourcing project.

• Assessing prints to determine geometric complexity of parts for validations.

• Conduct risk analysis study and documentation for products (Implants) and processes (Ultrasonic Cleaning Lines) - (PFMEA).

• Design validation plans, sampling plans, process flow diagram, product matrices and determine fixture and tooling requirements.

• Documentation and execution of OQ & PQ of various medical implants.

• Establishing preliminary routers and work order maintenance.

• Sorting through options and choosing the most appropriate processes and machining methods.

• Responsible for revising various SOP’s, GSOP’s and Work Instructions. Co-Founder & Product Development Engineer at 3DProtoEdit, LLC (10/2015 – 02/2016)

• Responsible for creating 3D printed models of organs as an assistive tool for surgery and as an educational tool for medical professionals.

• Coordinated all aspects of production, including selection of manufacturing methods & fabrication.

• Planned and evaluated results of analysis, modeling and experiments. Biomedical Engineer at Criticam Medical Systems (09/2012 – 06/2013)

• Maintenance and troubleshooting of biomedical equipment.

• Responsible for procurement and installation of over 75 biomedical equipment’s.

• Provide training to new nursing staff on medical equipment installed in the ICU. PROJECT WORK

Rotating Knee Femoral Insourcing Project ($1 million) (06/2016 – 09/2016)

• Successfully handled a $1million insourcing project.

• Responsible for verifying outsourced and insourced process changes.

• Responsible for determining, designing & documenting validation activities (OQ & PQ) for process change.

• Responsible for the pFMEA update and analyzing risk factors and RPN values of the new risk due to process change.

• Responsible for Router and BOM updates.

• Responsible for updating Work Instructions and Visual Aids for new part fixtures and tooling information. Vendor Outsourcing Projects for Bone Plates (03/2016 – present)

• Successfully handled multiple outsourcing projects resulting in the savings of almost $700,000.

• Verify completion of the SPPA process and vendor specific manufacturing processes.

• Verifying the completion of FAL and IIS activities before conducting the final clean execution.

• Determine worst-case parts after assessing prints and contact material list acquired from the vendor.

• Designed and documented validation activities required for OQ & PQ execution.

• Creating in-house routers and BOM’s for outsourced products.

• Determining part quantities & tooling and fixtures required for the OQ & PQ execution activities. TECHNICAL SKILLS

• Project management, SOP’s/GSOP’s, PFMEA risk analysis (Process, Product & Muti-Site), IQ, OQ & PQ execution and documentation, GDP, Quality System Regulations (FDA and ISO), SharePoint 2010, Microsoft Office, Biomedical Equipment Management.

PROFESSIONAL MEMBERSHIPS

• American Society for Quality (ASQ), APICS – The Premier Association for Supply Chain Management.