Tejas Ghushe
Pune
Summary
Results-oriented Mechanical Engineer at Capgemini Engineering with 4 years of experience in the medical device sector. Led a successful packaging design initiative that achieved $20K in cost savings, demonstrating strong teamwork and innovative thinking. Expertise in Design Control and risk management, alongside comprehensive knowledge of ISO 13485 and FDA 21 CFR Part 820. Dedicated to promoting project success through creative solutions and collaboration.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Test Method Site Transfer
Capgemini Engineering
Pune
02.2021 - Current
- For single-use catheters, transferred test methods from one site to another by providing engineering rationales, while achieving equivalent test method performance.
- Carried out a statistical equivalency study to showcase test method equivalency for fixture change in the test method using Power/Sample Size Analysis.
- Creation of the First Article Inspection/Tool Qualification plan considering CTQs, and execution of the First Article Inspection/Tool Qualification for class C items.
- Reverse engineering for fixtures in the case of COTS part obsolescence by the vendor, or any change to the COTS item.
- Equivalency generation for Class D items.
- Hands-on experience with machines like Laser Mike, HBLT, FTS, VMS, and Instron.
- Knowledge of Gage R&R and Analysis of Variance (ANOVA).
- Requirement identification, quotations, negotiations, and procurement of Class A, Class B, and Class C items.
Value Improvement Project (VIP) – Tip Damage.
Capgemini Engineering
Pune
02.2021 - Current
- For sheaths are a dilator product, proposed a packaging change with inputs from compliant data and product knowledge, which further got implemented as a design change.
- Value addition in terms of cost-saving of $20K.
- Carried out VOC for the new proposed solution.
Medical Device Sustaining
Capgemini Engineering
Pune
02.2021 - Current
- In the urology division, I played a key role in creating essential DHF (Design History File) documents, including Design Input Design Requirements (DIDR), Design Output Summary Record (DOSR), and Design Verification Master Plan/Record (DVMPR).
- Conducted comprehensive DHF gap assessments and successfully generated Tech Reports to address identified gaps. Developed Design Change Analysis (DCA) reports supporting the implementation of necessary design modifications.
- Worked on cross-functional documents like Task Analysis (TA), Hazard Analysis (HA), Design Failure Mode Analysis (DFMEA), and Risk Management Plan/Report (RMP/RMR).
- Carried out material assessment activities, such as substance reports (SR), device material assessments (DMA), and material characterization documents (MCD).
- Demonstrated exceptional diligence, ensuring compliance with standard regulations, and facilitating successful project outcomes.
DHF DMR Remediation Project.
Capgemini Engineering
Pune
02.2021 - Current
- Translated risk analysis spreadsheets according to client Quality Management Systems (QMS) requirements, ensuring accurate and compliant documentation.
- Created warning mapping sheets to map appropriate General Information Documents (GIDs) to relevant hazards, facilitating the implementation of necessary control measures.
- Verified and assessed the effectiveness of control measures through meticulous analysis and documentation in Design Verification Reports.
- Generated comprehensive risk management reports, providing stakeholders with clear insights into identified risk control measures and mitigation strategies.
Education
Certified CAD Engineer -
CAD CAM GURU
Pune01.2021
B. E. - Mechanical Engineering
Yashwantrao Chavan College of Engineering
Nagpur01.2019
Higher Secondary Certificate -
Yashoda High School & Junior College
Nagpur01.2014
Skills
- Windchill
- Design Control
- Risk Management
- Statistical Analysis
- SolidWorks
- AutoCAD
- EU-MDR
- MS Office
Certification
Completed training in EU-MDR, ISO 13485:2016 overview and Risk Management.
Languages
Marathi
First Language
English
Advanced (C1)
C1
Personal Information
- Gender: Male
- Marital Status: Bachelor
- Height: 5 feet 8 inches
- Hobbies: Snooker, Cricket and Listening Classical Music
Timeline
Value Improvement Project (VIP) – Tip Damage.
Capgemini Engineering
02.2021 - Current
Medical Device Sustaining
Capgemini Engineering
02.2021 - Current
DHF DMR Remediation Project.
Capgemini Engineering
02.2021 - Current
Test Method Site Transfer
Capgemini Engineering
02.2021 - Current
Certified CAD Engineer -
CAD CAM GURU
B. E. - Mechanical Engineering
Yashwantrao Chavan College of Engineering
Higher Secondary Certificate -
Yashoda High School & Junior College
Similar Profiles
Gowthami AshokkumarGowthami Ashokkumar
Professional Network Engineer at Capgemini EngineeringProfessional Network Engineer at Capgemini Engineering
Gagandeep Singh ChopraGagandeep Singh Chopra
IT Operations Manager (Network & Data Center Operations) at Capgemini EngineeringIT Operations Manager (Network & Data Center Operations) at Capgemini Engineering
Stuti SinhaStuti Sinha
Lead Recruiter | Consultant at Capgemini EngineeringLead Recruiter | Consultant at Capgemini Engineering