May 2024 – Mar 2026 · 1 yr 10 mos · Pune District, Maharashtra, India · Hybrid

• Client: Boston Scientific India
• Led cross-functional design & material change projects for Class II/III medical devices, ensuring compliance with FDA QSR, ISO 13485.
• Conducted impact assessments, risk analysis (FMEA), and developed DVPs, sampling plans, and DV reports using statistical analysis.
• Collaborated with cross-functional teams to lead the design and material change of Luers in the SpyScope device, ensuring compliance with ISO 80369-7 standards and successful implementation without impacting production timelines.
• Executed supplier addition projects to improve capacity, reduce lead times, and support cost savings and supply chain security and updated and maintained design control documentation (DOSR, DRF, Engineering Drawings), and supported regulatory documentation as per ISO 14971 and biocompatibility reports as per ISO 10993.
• Applied DMAIC problem-solving principle and collaborated with RA, QA, Manufacturing, and SMEs across Biocompatibility, Sterilization, and Microbiology for Design and process optimization.
• Demonstrated strong technical communication and project leadership, aligning global teams and stakeholders on design changes, timelines, and outcomes.
• Performed detailed tolerance analysis of mechanical assemblies to ensure that dimensional stack-ups met critical design and functional requirements across worst-case scenarios.

Apr 2023 – May 2024 · 1 yr 1 mo

Apr 2022 – Aug 2023 · 1 yr 4 mos

Sep 2020 – Nov 2022 · 2 yrs 2 mos

• Created solutions for technical problems using problem-solving methodologies and engineering principles such as DFSS
• Participated in design efforts over the continuum of product development and/or life cycle management
• Coordinated with cross-functional teams i.e. Quality, Marketing, Regulatory, Manufacturing Technology, Operations etc. to deliver the design solutions more effectively.
• Designed, developed, verified and validated test methods and prototypes as needed.
• Owned the design deliverables of the project assigned
• Optimized product design, material selection, product features, process design and human factor needs based on the project needs.
• Analyzed the design and utilize robust engineering principles to ensure that the design is optimized to satisfy product and business requirements.
• Ensured the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, serviceability, reliability and safety.
• Developed technical designs, DHFs, draft engineering and test plans, drawings, 3D models as needed.

Jan 2020 – Aug 2020 · 7 mos · Mumbai · On-site

• Responsible for the reverse engineering, design calculations and generation of BOM of various projects
• assigned to me.
• Developed detailed Solid models, POCs and drawings of Modular Furniture considering DFM and DFA.
• Conducted a cross-functional project team in developing products from concept through to commercialization.

Sep 2018 – Dec 2019 · 1 yr 3 mos · Thane, Maharashtra, India

• Developed understanding of various manufacturing processes like machining, 3D printing etc. to prototype the
• designs.
• Designed point-of-care devices in accordance with project objectives with due consideration of project schedule, budget & risks.
• Performed engineering calculations & analysis of complex scope like custom designed parts and OEM selection
• such as Motor, Bearings, Lead-screw Rods, Lens, Color Sensors etc. and ensured that the product met the requirements for DFM & DFA.
• Developed design risk assessment (FMEA & Hazard Analysis), implementing controls or mitigation to reduce risk
• levels.
• Developed various Jigs & Fixtures to ease the assembly process at the production line.
• Delivered Design Control Documents (DCD) in accordance with ISO 13485 and ISO 14971 Risk Management.

Jun 2018 – Sep 2018 · 3 mos · Navi Mumbai

• Assisted engineering team in solar energy system design
• Reviewed and revised drawings and design documents in compliance with codes and standards
• Did research on optimization of solar energy systems and prepared component drawings for prototype fabrication
• Conducted site visits to ensure harmonious operations of the project whilst dealing with the distributors and vendors to understand and provide desired requirements

Jun 2017 – Jul 2017 · 1 mo · Thane, India

• Repair and Maintenance of Regional State Transport Buses
• Learned how differential gear works
• Assembly and understanding the design of gearbox
• Understanding the role of the fuel pump and its installation
• Types of Radiators, their maintenance and role in the automobile industry