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.

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.

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.

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.

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.

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.

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

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

Doctor Of Philosophy (Phd), Mechanical Engineering

Master Of Science (Ms), Mechanical Engineering

Be, Mechanical Engineering