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Dev ashishDA
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Dev ashish

@devashish

Design Assurance Laboratory Engineer at Boston Scientific who validated 25+ test methods and cut testing turnaround time by approximately 25%.

India
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At Boston Scientific Technology & Engineering Services Pvt. Ltd., I lead design verification and test method validation activities for Class II medical devices. I led 8+ DV projects and developed and validated 25+ test methods, reducing testing turnaround time by approximately 25%.

I automated calibration tracking through BRMAR R3, improving compliance efficiency by 40%. I also support laboratory operations and capability development, including a Luer Gauge calibration feasibility assessment.

At Imperial Auto Industries Ltd., I executed DVP and PVP testing for fuel and brake systems, reducing test cycle time by 30%. I also led supplier quality improvement initiatives and developed PFMEA, Control Plans, and quality procedures.

My experience spans medical device and automotive quality and laboratory work. I’ve worked with ISO 13485, ISO 14971, FDA 21 CFR 820, IATF 16949, and ISO/IEC 17025, and hold a B.Tech in Mechanical Engineering.

Experience

Work history, roles, and key accomplishments

Boston Scientific Technology & Engineering Services Pvt. Ltd logoBL
Current

Engineer III – Design Assurance Laboratory

Sep 2019 - Present (7 years)

Lead design verification and test method validation for Class II medical devices, ensuring ISO 13485 compliance. Managed laboratory operations, automated calibration tracking, and mentored junior engineers.

TL

Engineer – QA

Toyoda Gosei Minda India Pvt. Ltd.

Jun 2011 - Nov 2012 (1 year 5 months)

Quality assurance engineer responsible for quality activities and compliance.

BL

Junior Engineer – QC

Bony Polymers Pvt. Ltd.

Aug 2009 - Jun 2011 (1 year 10 months)

Quality control engineer responsible for quality inspection and testing activities.

Education

Degrees, certifications, and relevant coursework

JU

J.R.N. Rajasthan Vidyapeeth University

Bachelor of Technology, Mechanical Engineering

Bachelor of Technology in Mechanical Engineering from J.R.N. Rajasthan Vidyapeeth University, completed in 2014.

MU

Maharshi Dayanand University

Bachelor of Science, Physics, Chemistry, and Mathematics

Bachelor of Science with majors in Physics, Chemistry, and Mathematics from Maharshi Dayanand University, completed in 2009.

HB

Haryana Board

Higher Secondary Education, Science

Higher Secondary Education in Science from Haryana Board, completed in 2004.

HB

Haryana Board

Matriculation, General

Matriculation from Haryana Board, completed in 2002.

Tech stack

Software and tools used professionally

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