Ranjan Nageri
Valencia,CA
Summary
Accomplished technical leader with over 20 years of experience in Class II and III medical devices, and a track record of leading complex implantable device projects from concept to commercialization. Demonstrated expertise in strategic planning and human resources management, effectively guiding high-performing, multidisciplinary teams through challenges. Proficient in mechanical, electromechanical, and biomedical engineering, complemented by a Black Belt in Design for Six Sigma. Aiming to leverage extensive experience to drive innovation and growth in medical technology.
Overview
20
20
years of professional experience
Work History
Sr. R&D Manager, Implantable Systems
Iota Biosciences
Alameda, CA
03.2024 - Current
- Led a high-performing, multi-disciplinary R&D team.
- Led the R&D team for a Class III neurostimulation system targeting a unique and complex urological indication. This system recently received FDA IDE approval.
- Executed development and management of neurostimulators, implantable leads, surgical instruments, and external electronics.
- Led execution of sophisticated implantable solutions for oncological and immunological applications.
- Collaborated with senior leadership, the CEO, on strategic planning, market research, reimbursement strategies, and product roadmap development for various neurostimulation indications.
- Worked with cross-functional leaders to create the AOP (Annual Operating Plan) and headcount strategies, and was responsible for tracking and reporting budgets.
R&D Manager
Boston Scientific
Valencia, CA
03.2021 - Current
- Collaborated regularly with senior leaders on strategic planning, technology roadmaps, resource allocation, and the globalization of R&D.
- Created and maintained a database of potential partners and vendors for collaborative projects.
- Developed comprehensive business plans for the introduction of new products into the marketplace.
- Effectively managed a budget of $10+ million for the R&D cost center, collaborating closely with Finance and the Project Management Office (PMO) to plan and oversee project budgets.
- Negotiated contracts with external suppliers, contractors, researchers, and consultants to ensure project success.
- Provided oversight for design reviews, testing activities, and quality assurance procedures on all prototypes.
- Led team meetings involving staff from various disciplines to align on project objectives and milestones.
- Regularly presented business plans, project updates, and technical progress to a broad audience, including site presidents, VPs, and franchise GMs.
Prin. R&D Engineer
Boston Scientific
Valencia, CA
09.2012 - 03.2021
- Mechanical and Electromechanical Tech Lead Successfully launched Avista™ MRI Conditional SCS Lead; Cartesia™ X and Cartesia™ HX DBS Directional Leads; Clik™-X, Clik-X-MRI Anchors; Competitive Adapters, and many other surgical accessories.
- Tech lead on numerous other NPD, Technology Development, and Exploratory Initiatives.
- Managed a team of diverse, experienced, high-performing R&D engineers, Process Engineering Technicians, and Product Specialists.
- Managed the Mechanical R&D Laboratory (inventory, training, and compliance).
- Interfaced with regulatory bodies, including FDA and TUV, to successfully navigate audits.
Senior R&D Engineer/Tech Lead
Covidien
Mansfield, MA
07.2008 - 09.2012
- Successfully launched a state-of-the-art mechanical DVT Prophylaxis product, a $450M revenue driver within the vascular compression landscape.
- Led cross-functional multi-site teams throughout developing products from concept to launch.
- Functioned as project manager/R&D lead on multiple new product development and iterative design improvement initiatives. Project budgets, on an average, exceeded $2M.
- Other responsibilities included managing design control deliverables, reporting to Project Portfolio Team (PIB), budget, time and resource management.
- Supported Regulatory affairs teams in building product technical files and registrations (US and Global).
R&D Engineer II
Boston Scientific
Marlborough, MA
05.2005 - 07.2008
- Responsible for design, development and continuous improvement of Venous Access products (Peripheral and Central Venous Catheters, Ports, Dialysis Catheters and Introducer Accessories) using Boston Scientific’s Product Development Process (PDP).
- Played key roles in all parts of a project- definition, planning, monitoring, controlling and closing.
- Responsible for maintaining DHFs and updates, Risk Management Work Books and Flowcharts.
- Led a site-wide process remediation project.
Education
Graduate Certificate in Project Management -
Stevens Institute of Technology
Hoboken, NJ12.2011
M.S, Plastics Process and Design Engineering -
University Of Massachusetts
Lowell, MA05.2005
B.S, Polymer Science and Technology -
University of Mysore
India05.2003
Skills
- Human Resources Management
- Strategic Planning
- Business Development
- Budget Management
- Project Monitoring
- Technology and Product Development
- Medical Devices
- Mechanical, Electromechanical, Biomedical
- Design for Six-Sigma, Black Belt
- Supplier Relationship Management
Skills
Comprehensive working knowledge of QSR, Design Controls, Process Validations, cGMP, GDP, SPC, SQC, FDA and EN ISO Standards including ISO 45502, 14708, 10555, 14971, 13485 and IEC 60601. Proficient in Solidworks, Minitab, MS Office.
Patents
- US-10639485-B2: Actuatable lead connector for an operating room cable assembly and methods of making and using.
- US-10543374-B2: Connector assemblies with bending limiters for electrical stimulation systems and methods of making and using same.
- US-10342983-B2: Systems and methods for making and using connector contact arrays for electrical stimulation systems.
- US-10905871-B2: Lead assemblies with arrangements to confirm alignment between terminals and contacts.
- US-2018028820-A1: Biased ball-spring contacts for electrical stimulation systems and methods of making and using same.
- US-11045656-B2: Biased lead connector for operating room cable assembly and methods of making and using.
- US-2015045865-A1: Systems and methods for making and using lead anchors for leads of electrical stimulation systems.
- US-10814127-B2: Slotted sleeve neurostimulation device.
- US-2015343198-A1: Systems and methods for making and using reversible mechanical lead anchors for electrical stimulation systems.
- US-2018147407-A1: Features in increased surface area on neuromodulation leads.
- US-11357992-B2: Connector assembly for an electrical stimulation system and methods of making and using.
- Others pending.
Additional Information
- Authorized to work in the US without sponsorship
Timeline
Sr. R&D Manager, Implantable Systems
Iota Biosciences
03.2024 - Current
R&D Manager
Boston Scientific
03.2021 - Current
Prin. R&D Engineer
Boston Scientific
09.2012 - 03.2021
Senior R&D Engineer/Tech Lead
Covidien
07.2008 - 09.2012
R&D Engineer II
Boston Scientific
05.2005 - 07.2008
Graduate Certificate in Project Management -
Stevens Institute of Technology
M.S, Plastics Process and Design Engineering -
University Of Massachusetts
B.S, Polymer Science and Technology -
University of Mysore
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