Tejas Kulkarni
R&D Engineer
Pune
Summary
Innovative R&D Engineer with extensive experience at Boston Scientific, specializing in medical device product development and sustaining. Proficient in PTC-CREO and FEA, I excel in leading design change initiatives, engineering analysis and collaborating with cross-functional teams. Known for meticulous DHF management and strong problem-solving skills, driving compliance and quality improvements.
Overview
9
9
years of professional experience
Work History
R&D Engineer 2
Boston Scientific
03.2022 - 02.2025
- Worked on R&D Sustaining Projects
- Worked on Design change, material change, supplier change projects
- Worked on DCA, conducted CCB meetings
- Co ordinated with divisional stakeholders
- Worked on DHF deliverables
Design and Test Engineer
Stryker Corporation
06.2019 - 03.2022
- Designed Test Fixture
- Conducted V&V Testings for Trauma& Extremities , joint replacement, instruments and medical divisions
- Worked on New product development project-Reverse shoulder implant
- Created Test reports
- Worked on DHF documentation
- Designed Concepts, performed engineering analysis
- Worked as an intern from June 2019-july 2020.
Engineer
Bharat forge Ltd. Pune
06.2016 - 12.2017
- Production planning and Supervisor, CMM Inspection
R&D Engineer 3
Boston Scientific
03.2025 - Current
• Conducted Design History File (DHF) and compliance assessments, updated documentation to meet Boston Scientific Quality Management System standards.
• Led test method validations, gap assessments, and technology remediation, including product design refinement and process capability studies.
• Directed design change activities
• Managed engineering documentation including design prints, specifications, BOM, and technical reports.
• Designed and coordinated engineering tests, experiments, and test fixtures.
• Evaluated change impacts on DHF, Device Master Record, risk files, and compliance documentation.
• Collaborated with cross-functional teams in process development, supplier engineering, quality, manufacturing, and regulatory compliance.
• Acting as point of contact for workstreams.
Education
Master Of Technology - Mechanical Engineering
VJTI
06.2020
Bachelor Of Engineering - Mechanical Engineering
Shivaji University
06.2016
HSC -
Maharashtra State Board
SSC -
Maharashtra State Board
Skills
PTC-CREO/SOLIDWORKS
Life Skills
- LEARNER
- RESTORATIVE
- STRATEGIC
- TEAM PLAYER
- ACHIEVER
Work History Details
- Bharat forge Ltd. Pune, Engineer, 06/2016 - 12/2017, Production planning and Supervisor, CMM Inspection,
- Stryker, Engineer, 06/2019 - 03/2022, Involved in New product Design and development (NPD), Worked on different phases of NPD from Research, Concept ideation, Design, planning, to V&V. Worked on project related technical documentation including different design and project deliverables. Worked on preparing user needs from VOC, Deriving design inputs, Designing parts and creating 3D CAD Models, Performing FMEA, Hazard identification, Involved in Risk management (RCM)., Involved in Project management and cross functional collaboration.
- Stryker, Test engineer - Perform Testability review of user needs, Develop Test strategy and test method, Perform V&V Planning., Design Test fixtures, Involve in DFM discussions, perform Fixture qualification, equipment qualification., Perform Verification & validation testing, Create Raw data and Test report, Perform Rapid prototyping activities, Knowledge of Additive manufacturing
- Boston Scientific, Design Engineer 1, 03/22 - Present, R&D Sustaining Projects
Extracurricular Activities
Actively Participated in CSR Social activities.
Projects
Design & development of shoulder arthroplasty implant using NPD and additive manufacturing process, Verification & validation of implant.
Acquired Skills
- Strong Technical skills
- Problem solving approach
- DFM, Design and manufacturing experience
- Strong Planning, management, leadership and decision-making skills
- Hands on experience on various Manufacturing machines and Inspection Instruments, Shop floor management
- Testing Fixture design and V&V Testing of medical devices
Honors Achievements
- Extra miler and Stryker superstar award
- R&D excellence award at boston scientific
- Cleared SSB and selected for the post of pilot In INDIAN NAVY
- HSC state merit list ranker and Awarded with INSPIRE Scholarship
- Involved in KAIZENS At Bharat Forge Limited
- Bachelors and Masters college gold medalist
- Obtained GATE score within top 5 percentile
Disclaimer
I hereby certify that the particulars given herein are true to the best of my knowledge and belief.
Timeline
R&D Engineer 3
Boston Scientific
03.2025 - Current
R&D Engineer 2
Boston Scientific
03.2022 - 02.2025
Design and Test Engineer
Stryker Corporation
06.2019 - 03.2022
Engineer
Bharat forge Ltd. Pune
06.2016 - 12.2017
Master Of Technology - Mechanical Engineering
VJTI
Bachelor Of Engineering - Mechanical Engineering
Shivaji University
HSC -
Maharashtra State Board
SSC -
Maharashtra State Board
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