Asahi Intecc USA, Vascular Treatment November 2023 – August 2025 Principal Quality Engineering
Working with cross functional team of R&D, Marketing, Operations to develop Thrombectomy System for blood clot removal.
- Led Design Control execution and maintained DHF in compliance with FDA standards.
- Collaborated with R&D, Marketing, and Operations to ensure design and manufacturing readiness.
- Develop Test Methods and validation to comply with regulatory requirements and international standards.
- Conducted Post Market Surveillance and integrated findings into risk management strategy.
- Supported manufacturing process development, document control, and equipment control process.
- Mentored junior engineers, fostering a culture of quality ownership and continuous improvement.
Becton Dickinson (BD), Medication Delivery System January 2014 – July 2023 Senior Staff Quality Engineer
Worked with cross functional team of R&D, Medical Affairs, Regulatory, Marketing and Operations with focus on design and development of Infusion specialty disposables. Promoted during first year of service in “BD2” (formerly CareFusion). Integrated business processes during acquisition of smaller company.
- Reconciled the Quality Management System for multiple business acquisitions to form a unified Quality Management System to be compliant and consistent with BD QMS, including DHF remediations.
- Worked as SME Risk Management Process including Risk Management Plan, System Hazard Analysis, Design/Process/Use FMEA, and Risk Management Report, following the ISO 14971.
- Supervised R&D Engineers for QA function (Design Controls) through commercial launch for multiple projects, including Combination Products.
- Trained personnel performing the design verification testing.
- Developed OEM Process based on Quality Agreement to specify roles and responsibilities of the Legal Manufacture and BD’s acceptance criteria to support the OEM Business.
- Actively participated in the decision-making process to optimize the product portfolio of Infusion disposables unit, resulted in approximate annual saving of $4 million. Remediated the Design History Files of the product portfolio.
- Drafted Design Development Plan, Protocol, Report and lead formal Design Review meetings with independent reviewers.
- Supported Situation Analysis Process based on the Post Market Surveillance Review and customer feedback.
- Led overall Risk Management Process including Risk Management Plan, System Hazard Analysis, and Risk Management Report.
- Improved the Business Unit’s Document Control system to be compliant with Design Controls.
Abbott Vascular, Cardiac Therapies April 2009 – December 2013
Senior Design Quality Engineer, April 2009 -August 2011
Senior Production Quality Engineer, September 2011 – December 2013
Worked with cross functional team of R&D for the development of new vascular product through commercial launch as SME of risk management and design control process.
- Led Risk Management Process by conducting FMEA of Use, Components, Design, and Process as part of product life cycle. Designed Input and Output through testing, verification, and commercial launch.
- Delivered Design Control deliverables and maintained Design History File (DHF).
- Applied Abbott’s Design for Excellence (DFX) Methodology and use of advanced statistical analysis pertaining to product / process characterization and improvement; conducted Test Method Validation with emphasis on Gage R&R.
- Supported manufacturing process for Operation Quality. Developed Inspection plan for manufacturing process monitoring and trending criteria establishing meaningful involvement of QE and QC on production floor to address the production anomalies.
- Conducted CAPA investigations, determining root causes, implementing corrective actions, and verification of effectiveness as overall CAPA process.
Abbott Spine - Spinal Implants and Instruments September 2007 to March 2009
Senior Design Quality Engineer
Worked with R&D team and Suppliers and conducted new material qualification at supplier’s facility and subsequently conducted the design verification testing and design validation on the output of the qualified material of specified material (Titanium for implants).
- Maintained the design history files (DHF), conducted assessment review at different phases, and remediated the DHF as needed to comply with the company policies and governmental regulations.
Additional Relevant Experience
Medtronic | Design Quality Engineer - Spinal Implants and Instruments
Ford Motor Company | Product Development Quality Engineer – Vehicle Body
