RAHEEL BAIG MIRZA
Irving
Summary
Goal oriented Product Stewardship, Quality and R&D Engineer with extensive experience in medical device design, product lifecycle management, and regulatory compliance. Proven expertise managing restricted substance requirements (RoHS, REACH, EU MDR), design verification & validation, and quality system documentation. Skilled at cross-functional collaboration to ensure product compliance, sustainability, and innovation.
Backed by an Executive MBA and a Master's in Mechanical Engineering, I integrate engineering rigor with strategic thinking to lead high-impact projects that align with business objectives.
I excel in bridging the gap between engineering teams and executive stakeholders, ensuring that technical execution fuels organizational success.
Overview
10
10
years of professional experience
Work History
Product Stewardship Engineer
Abbott Laboratories
Plymouth
08.2022 - Current
- Responsible for working in broader enterprise/cross-division business unit model.
- Support the implementation of a product stewardship database for Electrophysiology (EP) business unit.
- Responsible for working with multiple medical devices and product families like Structural heart Electro Physiology Catheters, Cables and Guidewires.
- Ensure part, packaging and product information is accurately tracked in database.
- Work for Corporate Regulatory/Product Stewardship team and provide updates as needed.
- Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Abbott Restricted Substance Management (RSM) requirements.
- Responsible for uploading RoHS and Reach certs in WPA.
- Responsible for supplier queries for EU MDR, REACH, RoHS for different product families.
- Facilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes.
- Facilitate division compliance with all RSM reporting requirements.
- Coordinate with R & D support, the implementation and integration of RSM evaluations.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Support Environmental Management System, ISO 14001 and division sustainability efforts.
- Responsible for restricted substance management (e.g., REACH, RoHS)
Senior R&D Engineer
Balt USA
Irvine
03.2021 - 08.2022
- Take Balt through product development process from design inputs, design outputs, test method development, feasibility, to get design documentation put together for Neurovascular stents and catheters.
- Develop/drive improvements for inspection test methods.
- Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports.
- Draft, approve, execute, and maintain relevant documentation such as design specifications, drawings, FMEAs, and facilitate validation protocols, as necessary.
- Execute design verification and validation testing create protocols and reports for all tests (delivery force, retrieval force, torque, tensile, radial strength)
- Drive implementation of opportunities to optimize/improve related processes including using engineering methods (e.g., SIX Sigma and Lean methods) while employing technical design skills to support the design of equipment, tools, fixtures.
- Review’s product and process changes for qualification and validation requirements and assists in change implementation.
- Collaborate with product development to develop test methodologies required to complete analysis of device designs.
- Develop test protocols for V&V testing including bench-top simulated use, animal studies and physician usability studies from scratch.
- Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and industry best practices.
- Conduct testing by developing test protocols as required. Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Responsible for Design Control, Device Master & Device History Records, Standard Operating Procedures review, Drawings/Specifications review, Change Orders, Quality Systems Manual and company-wide training.
- Responsible for authoring, reviewing and approving test protocols and reports for Design Verification and Validation (DVV) activities.
- Develop conditioning protocols for the devices.
- Active participant and leadership in Design and Phase Review meetings per design control internal procedure.
- Responsible for updating design history files (DHF) and product specification documents.
- Participates and/or review risk management activities including the development and authorization of product and process risk analyses, failure mode and effect analyses (FMEA’s), and risk assessments Inspection techniques, understanding technical documentation including mechanical drawings.
- Understanding of risk management principles for medical devices per ISO 14971.
- Understanding of quality management systems for medical devices per ISO 13485.
Product Stewardship Engineer
Abbott Laboratories
Plymouth
06.2020 - 02.2021
- Responsible for working in broader enterprise/cross-division business unit model.
- Support the implementation of a product stewardship database for Structural Heart business unit.
- Responsible for working with multiple medical devices and product families like Structural heart Occluders and Delivery Systems.
- Ensure part, packaging and product information is accurately tracked in database.
- Work for Corporate Regulatory/Product Stewardship team and provide updates as needed.
- Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Abbott Restricted Substance Management (RSM) requirements.
- Responsible for uploading RoHS and Reach certs in WPA.
- Responsible for supplier queries for EU MDR, REACH, RoHS for different product families.
- Facilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes.
- Facilitate division compliance with all RSM reporting requirements.
- Coordinate with R & D support, the implementation and integration of RSM evaluations.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Support Environmental Management System, ISO 14001 and division sustainability efforts.
- Responsible for restricted substance management (e.g., REACH, RoHS)
Development/Quality Engineer- Trauma/Lower Extremities
Zimmer Biomet
Warsaw
04.2019 - 04.2020
- Worked as Design History Files (DHF) owner to identify and rectify gaps following Good Documentation Practices (GDP) protocols.
- Prepared Design Input (DI) and product specification documents as an individual DHF owner based on product requirements.
- Linked Product specifications to their appropriate design inputs and User needs on ZB VAULT.
- Generated, reviewed Impact Assessment (IA) and Design Failure Mode and Effect Analysis (DFMEA) tables for analyzing the risk associated with medical devices.
- Analyzed risk as critical or non-critical based on Risk Priority Number (RPN).
- Collaborated with team leads in the preparation of Risk Management Plan for effective risk analysis and their documentation.
- Implemented efficient Design control and traceability matrix (DCTM) data organization on Zimmer Biomet Cognition Cockpit (VAULT) software for multiple DHF’s.
- Prepared Verification & Validation (V&V) reports and protocols to identify and compare the strength and failure mode for instruments and implants with their acceptance criteria.
- Performed post market engineering activities for Design History Files (DHFs) and implants following 21 CFR 820 Design Control guidelines and ISO (13485 and 14971) standards.
- Prepared Impact Assessment form and Implementation Plan for Drafting MC (Engineering Change) in Change Management Systems.
- Review and generate input/output tables or trace matrices (DCTM’s).
- Generate or analyze and update existing risk documentation (DFMEA or risk tables).
- Experience in reviewing existing design history files, identify scope, and mark gaps where necessary documents are missing.
- Experience with Product Life Management System (Team center).
- Coordinate, prepare, and conduct design reviews with cross functional teams.
- Perform functional relationship analyses (FRA) and tolerance stack-ups.
- Generate comprehensive protocols to test and analyze the product for design verification and design validation (V&V).
- Generate design assurance documentation for the project.
- Update prints and other design and manufacturing elements.
- Roles/responsibilities mainly included Requirement gathering, Modeling, Analyzing, Client interaction and Project deliveries.
Associate Engineer
National Biomechanics Institute
Los Angeles
02.2019 - 03.2019
- Responsible for determining kinematics and kinetics regarding an accident.
- Analyzed technical biomechanical reports explaining accident dynamics, injury mechanisms and human tolerances.
- Responsible for conducting simulations using PC-Crash, Virtual Crash and MADYMO.
- Proficient in examining cases pertaining to Motor Vehicle Collisions (Rear-Ends, Frontal, Side-Impacts, Roll-Overs), Pedestrian Impacts, Bicycle accidents and Cumulative trauma injuries.
- Responsible for performing full vehicle crash tests for different crash scenarios such as frontal, side and rear impacts using Virtual Crash, LS-DYNA and MADYMO software.
- Work with accident reconstruction engineer to determine how the accident took place.
- Dummy positioning, Seatbelt fitting and performed complete crash analysis using FE model development and simulations under FMVSS214, FMVSS 208 test conditions.
- Responsible in modeling lap belt three-point belts for automotive vehicle.
- Performing 3D scans of vehicles and scenes and photogrammetry analysis of vehicle crash damage.
- Evaluated critical injury parameters of the occupant and vehicle structural damage according FMVSS and IIHS regulations.
- Post-processing and documentation of numerical analysis results (stress analysis, load path analysis, energy plots, etc.) using Hyperworks, Matlab solver and MS-Excel.
Research Assistant
Wichita State University
Wichita
04.2018 - 12.2018
- ATV modeling and occupant injury analysis.
- Hyperloop occupant kinematic analysis.
- Oblique-facing rigid aircraft seat occupant injury analysis.
- Pedestrian safety analysis in case of collision.
- Frontal, side, knee airbag restraint system analysis.
- Performed analysis of structural deformations, energy absorption and dummy responses after impact using LS-Dyna.
Graduate Research Assistant (CAE)
Wichita State University
Wichita
08.2015 - 12.2017
- FEA modeling of full vehicle automotive components like side impact beam, suspension system etc., using Hypermesh.
- Performed component level tests, sled tests and full vehicle crash tests for different crash scenarios such as frontal, side and rear impacts using MSC-Adams, LS-DYNA and MADYMO software.
- Dummy positioning, Seatbelt fitting and performed complete crash analysis using FE model development and simulations on a compact car under FMVSS214 test conditions.
- Involved in modeling of lap belt for aircrafts and three-point belts for automotive, seat-belt routing and seat squash.
- Trained in debugging huge DYNA deck files in case of negative volume problems, node shoot out, contact penetrations, hourglass, energy abnormalities, simulation quality checks.
- Post-processing and documentation of numerical analysis results (stress analysis, load path analysis, energy plots, etc.) using Hyperworks, Matlab solver and MS-Excel.
- Assisted graduate and undergraduate students for several projects related to vehicle crashworthiness and occupant kinematics by providing technical support.
Education
Bachelor of Technology - Mechanical Engineering
Jawaharlal Nehru Technological University
Hyderabad, IndiaMaster of Science - Mechanical Engineering
Wichita State University
Wichita, KansasMaster of Business Administration - Project Management
University of the Cumberlands
Williamsburg, KYSkills
- Regulatory Compliance
- REACH RoHS Compliance
- Hazardous Materials Management
- Prop65, TSCA, Conflict Minerals and PPWR
- Medical Device Regulation (MDR)
- CAPA
- DFMEA
- Minitab
- Design Verification and Validation
- Test Method Validation
- ISO 13485 and ISO 14971
- Catia V5
- Solidworks
- Root Cause Analysis
- Geometric Dimension & Tolerance (GD&T)
- Quality tools
- Kaizen
- 5S
- DOE
- Altair Hyperworks
- LS-DYNA
- Ansys workbench
- CNC Programming (G & M Codes)
- Matlab
- Windchill
- CMAP
- MS-Office
Timeline
Product Stewardship Engineer
Abbott Laboratories
08.2022 - Current
Senior R&D Engineer
Balt USA
03.2021 - 08.2022
Product Stewardship Engineer
Abbott Laboratories
06.2020 - 02.2021
Development/Quality Engineer- Trauma/Lower Extremities
Zimmer Biomet
04.2019 - 04.2020
Associate Engineer
National Biomechanics Institute
02.2019 - 03.2019
Research Assistant
Wichita State University
04.2018 - 12.2018
Graduate Research Assistant (CAE)
Wichita State University
08.2015 - 12.2017
Bachelor of Technology - Mechanical Engineering
Jawaharlal Nehru Technological University
Master of Science - Mechanical Engineering
Wichita State University
Master of Business Administration - Project Management
University of the Cumberlands