Engineer with expertise in design, development, qualification and production of high-technology electromechanical systems and FDA-regulated medical devices and life sciences. Expertise: Understanding of Quality Systems Regulations (QSR 21 CFR Part 820), MDD/MDR, ISO13485 Ensure the DHF (Design History File) for new product is adequately maintained and complete each phase prior to product launch. Experience with drug delivery, drug elution, and implants/bioresorbable materials Collaborate, review, and approve all project plans, requirements, specifications, tests, test results, traceability, risk management documents, and reports) and maintain a robust Design History File Participate in technical design reviews, project phase reviews, Change Control Board reviews, and Post Market surveillance trend reviews.
Hi, I’m
Nirosh Kumar Kalasikam
Raynham,MA
Summary
Overview
7
years of professional experience
Work History
Dotcom LLC, Depuy Synthes
Design Quality Engineer
05.2020 - Current
Job overview
- Provided Quality Engineering support for Risk management remediation of Spinal Implants and surgical instrumentation for quality and EU MDR compliance
- Provided Quality Support for maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification, and brand extensions
- Supporting design control activities for NPD efforts
- Performed gap assessment on risk management documents (RMP, RAC, DFMEA, RMR, IOVV) for EU MDR 2017/745
- Develop risk assessment, defining inspection methodology and acceptance criteria
- Audit Participation, review, provide audit response for internal audits and external audits bodies such as BSI
- Provide leadership in the understanding of medical device regulations to other functions
- Work with departments such as R&D, Regulatory, Manufacturing, and Marketing to remediate and maintain design control documents (RTM, DFMEA, PFMEA, PMS etc.)
- Engineering support to New Product Development specifically in the areas of Risk Analysis, Test Method Development and Validation, Design Transfer to Manufacturing, and Verification and Validation Strategies
- Use risk assessment tools (e
- G., ISO 14971, FMEA s, Product Maps, Inspection Plans, etc.) Conduct/Lead process validation strategies (inclusive of IQ/OQ/PQ) based on relationship to design controls, CAPA, NC, etc
- Product Verification Testing Support and lead product Design Control activities for new product development efforts
- Conduct Procedure/Design Failure Mode Effects and Analysis
- Ensures that the product quality system entries are compliant, effective, and sustainable.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
I3 Infotek INC, GE Healthcare
Manufacturing/Quality Engineer
03.2018 - 05.2020
Job overview
- FAT, SAT, IQ, OQ and PQ of the equipment made to manufacture high units of Bio pharma products
- Planning and executing the process development builds and Validation Activities
- Support Change Control documentation for validation and equipment changes
- Identified and implemented robust CAPA’s by investigating and analyzing manufacturing problems
- Analyze process, product, material or equipment specifications and performance requirements
- Under broad supervision / guidance, compiles and analyses operational, test and experimental data to establish performance standards for newly implemented or modified products / processes
- Summarizes, analyses and draws conclusions from test results leading to effective technical resolution
- Troubleshoots new products / process working closely with product development
- Driving Continuous improvements in process design, layout and operational performance
- Actively promoted and participated in a cross -functional teamwork environment
- Evaluation in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect and to eliminate or lessen such impacts/effects on manufacturing
- Technical guidance to Associate Engineers and technicians
- Experience transitioning products from prototype to production desired
- Experience introducing new products and new processes into a production environment
- 2+ years of experience as a hands-on mechanical automation equipment as engineer II or project engineer working on electromechanical systems
- Preparation and project management of all line extensions / NPI including supporting documentation as required
- Solid works 3D CAD experience
- Effectively training manufacturing employees on specifications and processes
- Influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives
- Equipment Experience: Automated 2-Dimensional chamber making machine (Customized), Bar sealer, Port sealers, Tensile test Equipment, Flash Cutter and Burst Tester
- Identified problems and specific resolutions to fix defective, damaged or malfunctioning parts, assemblies, equipment and systems.
- Selected manufacturing methods, fabrication and operations to develop and coordinate production.
I3 InfoTek INC, Flex Medical
Quality Engineer
02.2017 - 02.2018
Job overview
- Participated in specified system internal audits, customer audits as well as the processes affecting the product design
- Control the processes and products qualities for design projects
- Ensured all inspection/testing equipment are controlled and calibrated
- Supported Non-conforming material investigation and disposition (NCMR)
- Worked with customers on quality issues for continuous improvement, perform internal/external corrective and preventive actions as required, and compile monthly reports for preventive actions
- Experienced inNon-conforming material investigation and disposition (NCMR), statistical data analysis using Minitab (Gage R&R, Anova studies)
- Led in development and execute Test Method Validations (TMVs), develop, execute, review and approve Validation protocols (IQ, OQ, and PQ) and reports
- Generate quality procedures, instructions, checklists, control plans and quality related documents, and ensure that they are followed accordingly and guiding in the interpretation of the quality/design and development plan
- Involved with design, quality and operation teams to identify and mitigate risk associated with hazards through Process FMEA
- Ensured PLC gate reviews are performed correctly per each phase
- Ensured design reviews (DIR, TRR, DOR, DTR) and technical reviews (EE schematic review, layout review, ME models review, drawings review, SW design reviews PER BUILD) are performed correctly per each phase and reports released and action items tracked
- Ensured build readiness reviews are performed correctly for each Feasibility(fx), Characterization (Cx), and DV builds
- Led multiple Life Cycle Engineering projects, conducted system level requirement analysis, worked closely with the Systems Engineers, RA, QA technicians focusing on Standard Operating Procedures (SOPs), IQ/OQ/PQ activities, test method validation and CAPA for effective workflow planning, execution and successful completion of verification activities of the project
- Verified project members are trained correctly on QMS, project specific documents (V&V plan, build protocol etc.) and training records maintained
- Approve suppliers for custom and critical components via QMS procedures
- Periodically review Risk management file (FMEA, RMP etc.)
- Supervise the day to day complaint handling process related to MDR and MDV reporting and all related activities
- Represent complaint management related to MDR and MDV functions during internal and external audits
- Developed traceability documentation to aid in investigating faults and defects.
I3 Infotek, Client : Baxter
Quality Engineer
07.2016 - 02.2017
Job overview
- Employed statistical tools to track process capability and determine root cause of deviations from specification to implement process improvements.
- Provide training to internal team members on the Company's complaint handling process, MDR and MDV processes and requirements
- Ensure that all complaints related to MDR and MDV requiring responses are properly addressed
- Led investigations of non-conforming products / processes to determine root cause, containment and design impact. Compiled technical reports in support of NCMR investigations, CAPAs and containment activities used to support quality decisions and responded to FDA 483 inspection observations.
- Led all product design related corrective and preventive actions (CAPAs) and Managed low risk Nonconforming Product Reports (NCR’s)
- Led Risk Management (U/DFMEA) workbook development while coordinating with R&D, PD, Clinical, Marketing, Packaging and Regulatory teams.
- Risk Management Plans, Risk Management Reports, Hazard Analysis Reports,Design FMEAs and Use FMEAs. Maintained Risk Management File in the electronic Design History File (DHF).
- Performed GAP Analysis of existing RM Plans and suggested Remediation activities.
- Implemented and managed Design History File (DHF), Functional design requirements, design input and output (I/O), design Verification and Validation (V&V), and design risk management analysis.
- Facilitated risk analysis meetings to determine failure modes, failure effects, severity, failure causes, probabilities of occurrence, RPN numbers, risk mitigations, implementation of risk control measures, residual risk evaluation, and risk/benefit analysis.
- Developed and executed Test Method Validation (TMV) protocols. Performed Gage R&R studies. Prepared TMV reports.
Education
Pittsburg State University
Masters from engineering technology (Mechanical
University Overview
New England CollageHenniker, NH
MBA from MBA
05.2021
University Overview
Skills
Broadly experienced in designing using AutoCAD, ANSYS, CATIA V5, CFX, SolidWorks and Engineering Drawing
Certified in SolidWorks Simulation Associate- Finite Element Analysis (CSWSA-FEA-ID-C-N96CY6SPBM)
Machining and Tooling: Milling, Lathe, Drilling, Riveting
- Quality Improvement Strategy
- Root Cause Analysis
- Engineering Support
- Diagnostic Automation
- Change Management
- Risk Mitigation
- Non-Conformance Processes
- Corrective Action Planning
- Risk Management
- Design and Manufacturing Reviews
Timeline
Design Quality Engineer
Dotcom LLC, Depuy Synthes
05.2020 - Current
Manufacturing/Quality Engineer
I3 Infotek INC, GE Healthcare
03.2018 - 05.2020
Quality Engineer
I3 InfoTek INC, Flex Medical
02.2017 - 02.2018
Quality Engineer
I3 Infotek, Client : Baxter
07.2016 - 02.2017
Pittsburg State University
Masters from engineering technology (Mechanical
New England Collage
MBA from MBA
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