Mounica Nandhini Poomal Raj
Senior Engineer (Combination Products)
Unionville,Ontario
Summary
Accomplished, versatile Engineer with expertise in design, development, qualification testing (V&V) and production of high-technology electromechanical systems and combination products. Applied knowledge of statistical process control (SPC), design failure modes and effects analysis (DFMEA), design for manufacturability (DFM), DOE analysis. Multi-discipline experience includes software validation, PFMEA risk analysis, creating bills of material (BOM) and part processing (routers), initiating and completing Operational Qualifications (OQ), Performance Qualifications (PQ), and Installation Qualifications (IQ): includes executing and evaluating Process Testing using statistical analysis for long-term stability.
Overview
6
6
years of professional experience
37
37
years of post-secondary education
4
4
Languages
Work History
Sr. Engineer (Combination Products Lead)
Amgen Inc.
07.2020 - Current
- Manage four junior engineers reporting to me directly
- Involved in technical and managerial discussions with leadership on a regular basis
- Conduct technical investigations of Level 2 and 3 complaints associated with product design and/ or usability issues and conduct trend and consolidated investigations using data analytics
- Own and monitor CAPA implementation and timeline
- Participate in multi-functional ideation of design solutions and support feasibility assessment of design options identified
- Evaluate CAPA Effectiveness Verification including determination of acceptance criteria and data collection period
- Maintain close interaction with the engineering and quality functions to contribute to product development and continuous product and process improvement
- Conduct performance evaluations for my team and report to leadership
- Lead quality improvement activities using methods such as Kaizen and Six Sigma
- Lead root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices and associated product components such as packaging returned due to product complaint using root cause analysis
- Coordinate with supply chain and act as liaison with suppliers, initiate and review SICARs/SCARs
- Review SICAR/SCAR forms and approve supplier CAPA implementation plans and timelines
- Participate in Internal and External regulatory audits, assist Regulatory Affairs, Quality Compliance team with audit prep
- Perform failure analysis using tools and processes to identify root cause using tools such as tolerance analysis, fishbone diagrams, '5 Whys', and risk assessments such as FMEA's or Fault Tree Analysis
- Proficient with equipments such as CT scanners, FTIR material analysis and Instron tensile test machines
- Lead multi-functional conceptualization of design solutions to reduce complaints based on output of root cause analysis, resolve feasibility of options through testing and analysis, develop business plans for implementation
- Perform trend analysis and technical consolidated investigations on failures, Deviation and NonConformance Investigations (NCI)
- Deep dive into observed trends or signals by using statistical assessment and generate monthly reports
- Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
- Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
- Develop and perform relational data analytics in support of investigations
- Advise management for trend and failure investigation process improvement
- Provide guidance to engineering for product improvements
- Support functional management initiatives and objective.
Sr. Quality Test Engineer
FLEX LTD.
02.2019 - 07.2020
- Strategize verification and validation testing of Class I, II and III medical devices
- Developed and implemented test cases, test protocols and test plans to accurately perform test that meet product and design requirement specifications, regulatory requirements and quality objectives
- Wrote reports to document test results and quality activities during test method validation protocols and verification protocols execution
- Authored Master Verification and Validation Plan (MVVP), Test Plan for different FPLC phases, Test Flow, Test Schedules, etc
- Supported continuous product and process improvement through detailed failure analysis for nonconformances, and investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program)
- Performed root cause analysis (RCA) to investigate material and part non-conformance and generate non-conformance report (NCR)
- Support root cause analysis using tools like Hazard Analysis, 5 Whys, Pareto Charts, Fish Bone Diagram and Fault Tree Analysis
- Generated and route Engineering Change Requests (ECRs), Change Impact Assessment Forms (CIAF) and Engineering Change Orders (ECOs)
- Performed engineering studies and statistical data analysis using Minitab
- Specified quality characteristics and inspection plans for components, subassemblies, and finished devices
- Analyzed and investigated returned products to determine the cause for return and recommend Corrective and Preventive Actions (CAPA)
- Schedule, setup, and execute environmental and mechanical reliability tests like life cycle test, aging test (HALT, HASS), temperature/humidity/altitude, tensile/compression, shear, pull, drop, burst pressure, mechanical shock & vibration test, acoustic test, ASTM/ISO tests, IEC 60601, Ingress Protection (IP), packaging tests (ISTA), etc
- Implemented changes in manufacturing methods, processes and product production planning documentation as appropriate
- Documented all changes through the appropriate change control system
- Supports quality engineering activities such as DHF gap closure, Product Technical Requirement (PTR) development and testing, Packaging development and testing, Risk Management gap closure as needed
- Used GD&T per ASME Y14.5, design integrity, materials, tolerances, surface finish call-outs etc., to interpret designs, blueprints and engineering drawings
- Assisted Systems Engineer with System Level (PRD/DRD) to Sub-system Level Requirements breakdown (MRS/ERS/SRS or SyRS) and Trace Matrix
- Assisted Process Engineers during various phase builds and performed Process Validation (IQ/OQ/PQ and PV) of assembly/manufacturing processes, custom tooling/fixtures and TMV of test equipment
- Gained multidisciplinary experience by performing software validations (GAMP 3, 4, 5 category)
- Worked with Automation Engineers to write URS, SAT/FAT (Site Acceptance Test/Field Acceptance Test) and TMV protocols for fixtures and tooling used for design verification testing
- Identify non-conforming issues during manufacturing and document the issues in Non-conforming Material Record (NCMR)
- Implemented Device Master Record (DMR), including Bill of Materials (BOM), routers and procedure ensuring compliance with product specifications
- Analyzed, developed and troubleshoot manufacturing activities to improve process, product quality and costs complying with cGMP's, ISO, Safety Health, Quality Standards, Statistical Regulations and established policies and procedures
- Detailed experience in NCR, NCMRs, Process Validation, TMV, Equipment Qualification, Supplier Quality Verification, proves validation documentation (IQ/OQ/PQ) in compliance to FDR 21 CFR and GxP Regulations
- Generated and implemented Test Method Validation/Gage R&R plan and report.
Product Development Engineer
DunAn Sensing, LLC
02.2018 - 01.2019
- Developed concepts for New Product Introduction of Temperature and Pressure sensors (MEMS and Alumina Ceramic): 0-5V/0-10V, 4-20 mA, I2C, SPI and create specifications - this includes mechanical design and materials selection
- Ensured process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation
- Designed and developed process for laser welding, and active alloy brazing
- Designed assembly and packaging for new pressure sensor using low pressure molding technique
- Knowledge and experience with die attach, eutectic, wire-bonding, soldering, brazing, thick-film and thin-film printing, housing package crimping, die-pad crimping, PCBA manufacturing (surface mount SMT), flip-chip assembly, etc
- Designed low-cost housings, test fixtures and tools using GD&T per ASME14.5, SPC and fabrication techniques: used Solidworks Professional
- Created and released BOMs for new products
- Conducted FEA: static & thermal analysis (linear and non-linear) on the assembly components using Solidworks Simulation and ANSYS
- Conducted design of experiments (DOE) to identify critical variables in a process and establish design limitations
- Coordinated with software development team to develop calibration protocol for pressure sensors and support test development based on test system
- Testing and troubleshooting products and test systems
- Analysis of test data to write a report and release new product to manufacturing
- Conducted Qualification tests (mechanical shock/vibration, helium leak and gas leakage tests, thermal shock in air and water tests, salt spray, environmental exposure tests, burst pressure, Ingress Protection IP67, IP69K, etc) of new products and authored Qualification report
- Conducted DFMEA, PFMEA, Control Plans, authored PPAP documents for new products and Manufacturing Work Procedures (MWPs) for new processes
- Implement designs directed by managers and project engineers into CAD models (Solidworks) and released drawings into HQMS
- Perform complex press fits/interference fit checks and tolerance stack-up analysis
- Reviewed customer specifications to provide product solutions and samples
- Qualified products, high throughput processes and equipment for high-growth product lines
- Own all NPI and production quality activities including monitoring process build, incoming & outgoing inspection and lot release
- Review and update assembly process work instructions/traveler
- Mentor and grow the team to support aggressive revenue expansion
- In-line process monitor and review action plan to ensure no deviation in assembly process
- Responsible for Internal Quality Management audit, doc control and internal line audits
- Generate weekly yield, CT and OTD reports.
Mechanical Design Engineer (Intern)
Goldengate Mechanical Inc
10.2017 - 01.2018
- Design/redesign mechanical portions of Secure-ALL locks and U-keys to meet new market requirements using CAD Tools (Solidworks, CATIA, etc)
- Design tooling to be used by customers/installers to achieve zero-defect installations
- Test and validate components and assemblies
- Develop fabrication and cost estimation drawings for suppliers
- Write installation and user manuals as required
- Generate rapid prototypes utilizing standard machine shop equipment, as well as 3D modelling
- Set up QA procedures at vendors and the Secure-ALL manufacturing area
- Perform failure analysis (DFMEA, PFMEA, Risk analysis) as needed to identify and correct design flaws.
Education
MBA - Business And Organizational Administration
Campbellsville University
Louisville, KY 05.2001 - 05.2022
Master of Science - Aerospace Engineering
Wichita State University
Wichita, KS 05.2001 - 05.2017
Bachelor of Technology in Aeronautical Engineering - undefined
Jawaharlal Nehru Technological University
Skills
MS Office
Laminated Composite Manufacturing
Injection Molding
Low Pressure Molding
Stress Analysis
Mechanical Reliability Testing
Understanding of FAA part 21, 23, 25, EASA part 25
GD&T
ASTM & ISO Test Standards
FMVSS 214
IIHS
IQ
OQ
PQ
DFMEA
PFMEA
Risk Management
CAPA
CAPA Effectiveness Verification (EV)
BOM
ISO 9001
ISO 13485
21 CFR 820 standards
C
C
MATLAB (Basics)
Training
- Finite Element Analysis
- Mechanics of Laminated Composites
- Vibration Analysis
- Advance Mechanics of Materials
- Theory of Elasticity
- Structural Dynamics
- Thermodynamics
- Production Technology
- Project Management
- Marketing Management
- Finance
- Statistics
Timeline
Sr. Engineer (Combination Products Lead)
Amgen Inc.
07.2020 - Current
Sr. Quality Test Engineer
FLEX LTD.
02.2019 - 07.2020
Product Development Engineer
DunAn Sensing, LLC
02.2018 - 01.2019
Mechanical Design Engineer (Intern)
Goldengate Mechanical Inc
10.2017 - 01.2018
MBA - Business And Organizational Administration
Campbellsville University
05.2001 - 05.2022
Master of Science - Aerospace Engineering
Wichita State University
05.2001 - 05.2017
Bachelor of Technology in Aeronautical Engineering - undefined
Jawaharlal Nehru Technological University