Sameer Tendulkar Email & Phone Number

Raleigh, Nc, Us

Durham, North Carolina, Us

Toronto, Ontario, Ca

Tempe, Arizona, Us

• Design and develop implants and/or implant components for chronically implantable active medical (Class III) devices.• Design and develop fixtures and hardware for the manufacture and testing of implants.• Conduct brainstorming sessions and design reviews, build prototypes, release designs under design and document control.• Work with external labs to perform Biocompatibility testing and analysis for active implantable medical devices.• Develop, document and validate new processes for various manufacturing operations relating to new implant designs.• Execute/manage small to medium sized projects, perform project design and status review presentations.• Experience with medical device design standards and regulations (ISO 14708-1/-3, ANSI/AAMI C186:2017 and IEC 60601-1).• Manage external vendors and contract manufacturers.• Manage and mentor junior engineers.

Carlsbad, California, Us

• Developed design specifications, new concepts and prototypes for active implantable medical (class II and III) products.• Authored and executed verification and validation plans.• Led a cross-functional team of three members (which included clinical, quality/regulatory and marketing) to introduce new single use disposable wearable products.• Developed project schedules and drive projects to completion on time.• Managed and developed the single use disposable wearable components of the Nalu System• Implemented cost improvement projects that led to 20% savings (in the short term) and outlined the path for an additional 30% savings in the longer term.• Searched and developed a DME for distribution of wearable components of the Nalu system.• Participated in mechanical design review and analysis.• Designed and created test methods, equipment and fixtures.• Worked hands-on in the lab to characterize, test, debug designs and demonstrate regulatory compliance. • Worked with cross-functional teams to generate risk analysis documentation including Hazard Analysis, dFMEA and pFMEA. • Managed external vendors and contract manufacturers.• Maintained knowledge of evolving clinical environment.• Researched and defined applicable human factors specifications and acceptance criteria.• Experienced with Medical device design standards and regulations (FDA CFR #21 Section 820, ISO 13485, ISO 14708-1, ISO 14708-3, ISO 14971, ISO 11607-1, IEC 60601-1 and IEC 60601-1-11).• Managed and mentored junior engineers.

Marlborough, Ma, Us

• Created design substantiations and reviewed CAD drawings for design changes made to Class III products.• Conducted design and process change analysis by working with team members from R&D, operations, quality & regulatory.• Implemented design and process changes while working with various functions like R&D, operations, quality and regulatory.• Communicated product design and FMM (foreign and missing material) changes to higher management and aiding in decisions regarding field actions for the product.• Created design change tables and technical summaries for regulatory team to aid with FDA Real-Time Review.• Subject Matter Expert (SME) for fluid mechanics.• Demonstrated knowledge of design controls, PDP/TDP, risk management (dFMEA, pFMEA, product safety reports, etc.) and quality systems (FDA CFR part 21 Sec 820 & ISO 13485).• Managed and mentored two junior engineers.

Marlborough, Ma, Us

• Planned and managed target/clinical rationales, developing product specifications and performance parameters for class III long term implantable products (AMS 700 and Ambicor).• Conducted and lead technical reviews and dispositions.• Mentored junior engineers and interns.Equipment Lifecycle & Trace Control Forms• Successfully managed and trained multiple teams (15 and 8 members) to implement new processes that led to improved quality and on-time deliverables while saving the client excess of $100,000 over a period of 6 months.• Successfully created and implemented 490+ trace control forms (TCFs) as per FDA CFR#21 and ISO 13485.• Developed Equipment Requirements, Installation Qualification Protocols, Test Fixtures and Reports. • Implemented new TCF’s on the production floor.Skills/Equipment/Softwares:Microsoft Office, Minitab, Cognition Cockpit, GD&T, Microsoft Project, Windchill PLM, Agile PLM, FDA CFR #21, ISO 13485, Statistical Analysis, Good Documentation Practices, communication across various teams, Leadership and Mentoring, Equipment requirements, Installation Qualification, Agile PLM, Engineering Change Orders/Notifications, Trace Control Forms, Cleanroom Environment (CE), DHF, CFR #21, ISO 13485, Gage R&R studies, Cause and effect diagrams, Good Documentation Practices, communication skills, etc.

Raleigh, North Carolina, Us

• Created 3D CAD model and conducted FEA analysis using Solidworks that led to the engineering team to gain much needed information into the failure of the product.• Crafted a video tutorial for disassembly of the water-metering module to expedite the training of new hires.• Worked with cross functional teams involving mechanical, electrical engineers and technicians.Skills/Equipment/Softwares:Worked in multidisciplinary team involving mechanical and electrical engineers and technicians, SolidWorks (FEA Analysis), Oscilloscopes, Digital Multimeters, etc.

Raleigh, North Carolina, Us

Involved with MedTech-ID (Medical Technology Innovation & Design)Responsibilities and Accomplishments:•Identify and assess needs in cardiovascular, ADHD and sleep apnea space by observing surgeries and conducting interviews•Work closely with industry professionals to filter needs based on market analysis and development of new product/technology with consideration for IP and regulations•Conduct patent search to check existing IP and technologies•Submit grant applications and make technical presentations •Led to filing of provisional patent in ADHD and sleep apnea Skills/Equipment/Softwares:Communication and networking with various stake holders, Patent search, Grant writing, Technical presentations, design and document controls (DHF, FDA, ISO, CFR #21 etc.)

Raleigh, North Carolina, Us

Responsibilities and Duties:•Conduct background research and in depth analysis of existing products and technologies •Formulate the problem statement and write down design constraints•Design the device using 3D CAD and create numerical model to run simulations•Contact vendors for quotes and discuss manufacturing processes, update part design as needed and/or collaborate with them to customize fabrication process to minimize cost in order to source parts for the device•Develop, build and prototype custom parts on 3D printer as and when required for testing the device•Design and conduct in depth experiments to test prototype and validate simulation (numerical) model•Use of high speed video experiments as and when needed to study more intricate aspects of the process during experimentation phase•Collaborate and work with cross functional teams at Institute for Regenerative Medicine •Mentor and train junior researchers Accomplishments:•Research led to an IP application along with 3 publications, an international poster presentation along with a couple of grant proposals for NSF and NIH•Visit to New Zealand to present our technology to Living Cell Technologies•Considered one of the subject matter experts for use of in house 3D printer and high speed camera. Provided regular consult for other grad students, Professors and undergrad students regarding application to their projects •Successfully completed a leadership development certification and 2 teaching certificationsSkills/Equipment/Softwares:SolidWorks (3D CAD and basic fluid flow analysis), Ansys Fluent (droplet formation-single and multiphase flows), Microsoft Excel (Statistical Analysis), 3D printer (Dimension Elite 3D printer, Viper si2 SLA system), High speed camera (HotShot Mega Sc by NAC Image Technology), Microscopy (Olympus BH-2 UMA, Stereo microscopes), PLC Programming on Omron PLC, Technical Writing (Publications, Posters, Presentations, Grant Proposals, etc.)

Winston-Salem, Nc, Us

Responsibilities and Duties:•Prepare (fluorescently label) proteins for encapsulation •Conduct in depth parametric study to understand the protein encapsulation process for future optimization•Work and collaborate with multidisciplinary teams including but not limited to transplant surgeons, chemical engineers, biologists, biomedical engineers and biochemists•Mentor two junior scientistsAchievements:•Developed a standard protocol/ operating procedure for fluorescent labelling of protein•Designed, analyzed, prototyped and demonstrated a functioning microfluidic device to improve and optimize the protein encapsulation process to reduce operating costs. The amount of operating fluid required for each run of the encapsulation experiment was reduced by 70% from 10 ml to 3 ml leading to tremendous savingsSkills/Equipment/Softwares:Microplate Reader (SpectraMax M5, Molecular Devices), SolidWorks (3D CAD and basic fluid flow analysis), Ansys Fluent (droplet formation-single and multiphase flows), Microsoft Excel (Statistical Analysis), 3D printer (Dimension Elite 3D printer, Viper si2 SLA system), Microscopy (Olympus BH-2 UMA, Stereo microscopes), Technical Writing (Publications, Posters, Presentations, Grant Proposals, etc.)

Doctor Of Philosophy (Phd), Mechanical Engineering

Master Of Science (Ms), Mechanical Engineering

Be, Mechanical Engineering