Govindan Suresh work email
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Govindan Suresh personal email
I am a seasoned biomedical technical consultant with a wealth of experience accumulated over 7 years in prestigious multinational medical device companies across the USA & Australia.π Educational Background: I hold a Master's degree in Electronics & Biomedical Engineering from Michigan Technological University, USA, laying the foundation for my eventful career in healthcare technology.πΌ Career Journey: My professional journey began as a Research Assistant in the Biosensor lab at Michigan Technological University, where I delved into cutting-edge research on wireless implantable sensor technology for bone healing. Subsequently, I honed my skills as a Development Engineer at Zimmer Biomet (Indiana, USA) and later as a Product Quality Engineer at Philips Healthcare (Boston, USA), specializing in Design Control, Risk Management, Regulatory Compliance, and Quality Assurance. Since 2020, I've been a pivotal member of The OR Company (ORC) in Melbourne, where I've contributed my expertise as a Senior Product Development Associate, particularly focusing on gynecological surgical devices. Recently, I transitioned into a consulting role, leveraging my extensive experience in product ideation, design, development, quality assurance, and regulatory compliance to offer bespoke solutions.π‘ Why Choose Me?π Specialized Expertise: As a consultant, I provide technical, quality, and regulatory documentation assistance tailored specifically for startup medical device companies.π Comprehensive Services: From Regulatory Compliance and Document Creation to Design Control Implementation and Risk Management, I offer a holistic suite of services to ensure seamless compliance and product excellence.π Collaborative Approach: My collaborative ethos fosters cross-functional synergy, driving efficient processes and initiatives such as Verification & Validation, Change Control Management, Quality System Implementation, and Continuous Improvement.π Empowering Solutions: Committed to driving excellence, I offer comprehensive training and education programs to empower teams and enhance risk communication strategies.π¬ Let's Connect: Intrigued by my journey and services? I'm eager to connect with professionals who share a passion for innovation and excellence. Let's collaborate and propel your company's vision to new heights!
Aaroha Consultancy Services
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Biomedical Technical ConsultantAaroha Consultancy Services Aug 2023 - PresentMelbourne, Victoria, Australia
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Senior Product Development AssociateSymmetry Surgical Feb 2023 - Aug 2023Melbourne, Victoria, AustraliaNew Product Development: Conduct market research, oversee concept designs, develop V&V test protocols, draft specifications for device manufacturing & create a comprehensive technical file/DHF.Existing Products Maintenance: Solve all customer-related queries/complaints, maintain technical files to comply with regulatory standards, and lead design reviews/design changes to update product designs.Support regulatory activities to achieve & maintain TGA, CE & FDA certification. -
Product Development/ Design Control AssociateThe O.R. Company/ Symmetry Surgical Jun 2020 - Feb 2023Melbourne, Victoria, Australia
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Product Quality EngineerPhilips Feb 2019 - Dec 2019Andover, MaA Key contributor during design integration and NPI projects by ensuring Quality Management System processes are followedappropriately during the course of a project. A contributor to various deliverables within Design Control (per CFR and ISO 13485),Risk Management (per ISO 14971), Verification, Validation, Instructions For Use (IFU)/Directions For Use (DFU) and labelingreviews.ο· Lead Design Integration Assessment to assess the completeness of the processes, tools, and technical documentation for integrationinto the Philips Quality Management System following the acquisition of an external business unit.ο· Lead Design History File (DHF) reviews for various NPI projects and major design changes. Work in collaboration with otherfunctions to resolve gaps generated from the DHF reviews and successful dispositioning of the products that meet customer andregulatory expectationsο· Develop and implement systems and processes to ensure products or services are designed and sustained to meet or exceedcustomer requirements and expectationsο· Assist with DHF remediation, propose corrections to the records to bring them in compliance, and would result in no audit findings -
Development EngineerZimmer Biomet Mar 2017 - Feb 2019Warsaw, Indianaβ’ Perform DHF/DHR remediation of intramedullary implants and instruments in accordance with requirements set per 21 CFR Part 820 βQuality System Regulation.β’ Develop and update Design Control documents (DCTM) by identifying user needs, design inputs, design outputs, and design verification and validation as per FDA 21 CFR Part 820 and ISO 13485.β’ Review existing DHFs, identify scope and perform Gap Analysis and Gap Closure for the medical devices based on their design inputs. Analyze critical, major and minor gaps.β’ Draft technical memos, justification reports as a part of gap closures and update design history files to be compliant with Quality Management Standards (FDA, ISO 13485).β’ Act as a facilitator of continuous improvement by analyzing, identifying and updating the risk tables (dFMEA, pFMEA)for all the implants and instrumentsβ’ Analyze and update existing risk documentation (DFMEA or risk tables)β’ Create and/or modify definitive Product Specifications for implants and instruments based on engineering drawings (GD&T) by matching user needs and design inputs.β’ Collaborate with the quality and regulatory engineering departments to update current design controls of reusable instrumentation to meet current FDA requirements -
Graduate Research AssistantMichigan Technological University,Biosensors Lab Oct 2015 - Dec 2016Houghton,Mi
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Software TraineeQuest Innovative Solutions Sep 2014 - Dec 2014Kerala,IndiaUndertook training in MATLAB and SIMULINK in the field of signal processing and image processing.
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TraineeTrivandrum Medical College Apr 2012 - May 2012Kerala,IndiaTrivandrum Medical College is one of the finest medical college in the country.Their I was able to familiarize with the hospital equipment and facilities and also with the basic layout of the hospital and the functioning of the biomedical department as per the curriculum.
Govindan Suresh Skills
Govindan Suresh Education Details
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Biomedical/Medical Engineering -
Model Enginering College/CusatElectronics And Biomedical Engineering -
Bharatiya Vidya Bhavan
Frequently Asked Questions about Govindan Suresh
What company does Govindan Suresh work for?
Govindan Suresh works for Aaroha Consultancy Services
What is Govindan Suresh's role at the current company?
Govindan Suresh's current role is Biomedical Consultant: Technical, Regulatory, and Quality Documentation Expert Specializing in creating Quality Management System framework, documenting compliant DHF & DMR Empowering Startup Medical Device Ventures".
What is Govindan Suresh's email address?
Govindan Suresh's email address is go****@****ips.com
What schools did Govindan Suresh attend?
Govindan Suresh attended Michigan Technological University, Model Enginering College/cusat, Bharatiya Vidya Bhavan.
What skills is Govindan Suresh known for?
Govindan Suresh has skills like Matlab, C, C++, Microsoft Office, Biomedical Engineering, Microsoft Excel, Microsoft Word, Powerpoint, Windows, Signal Processing.
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