SUMMARY:

• Engineering professional with more than 4 years of experience in the Medical device manufacturing providing services including but not limited to design changes, process changes, supplier changes, remediation, recertification and product line transfers and implementations. Supported design control and design transfer activities for product development efforts. Support product development and design through verification and validation activities.
• Developed risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of suppliers as part of the project teams. Support test method validations. Communicated with cross functional teams at various levels in the organizations such as R&D, Regulatory, Manufacturing and Post Marketing Surveillance
• Working Knowledge of manufacturing quality toolset including PFMEA, process validation, product design control, NCMR, CAPA, DHF, GD&T, FMEA and six sigma methodologies. Supported Risk Management program, including creating Risk Management Plans, coordinating risk analyses, participating in FMEA’s, and maintaining Risk Management Reports and Files.
• Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes. Knowledge of new product development: Design Controls, Quality Planning, compliance including DHF/IDF, Verification and Validation, Risk Management, Process Validation (IQ/OQ/PQ) protocols and reports.

TECHNICAL SKILLS:

• ISO 9001, ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management,Devices) 21 CFR Part 820 (FDA Devices, US) 21 CFR Part 11 (FDA Software, US)/ CSV/Quality System Regulation (QSR) Corrective Action and Preventive Action (CAPA) Advanced Statistical Root Cause Analysis Risk Analysis Failure Mode Effective Analysis (FMEA: Design DFMEA & Process PFMEA)
• Nonconformance Material Report (NCMR) Design of Experiments (DOE) Change Control GAP Analysis Design Control Design History File (DHF) Validation Test Plans (IQ, OQ, PQ)
• LIMS/Track Wise Validation Summary Report Process Capability Study Test Method Validation (TMV) Gage R & R Process Control Plan Quality System Management Complaint Handling Reliability Analysis BOM’s 510 (k) New Product Development (NPD) Design Verification Supplier Qualification Incoming Quality Computation & Simulation - MATLAB/Six Sigma/Lean Manufacturing Statistical Analysis - Minitab tools

PROFESSIONAL EXPERIENCE:

Confidential, Maple Grove, MN

Sr. Manufacturing Engineer

Responsibilities:

• Utilized quality engineering and lean tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development.
• Experience with various levels of software testing scripts ( IQ, OQ, PQ ), Traceability Matrix, and Validation Reports.
• Investigated instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions.
• Analyzed routine and test data for improvement opportunities.
• Interfaced with Customers during sourceinspections. Resolved the Customer’s concerns and the non-conformances (NCMRs) through root cause / corrective action (CAPA) activities.
• Supported validations to assure all processes comply with company specifications to include internal quality systems and ISO requirements as well as applicable regulations.
• Reviewed and approved all associated documentation including risk management files and quality records.
• Developed quality plans, inspection procedures and control plans for new product development and delivery.
• Participated in Cost Reduction Activities and product redesigns.
• Developed and maintained Control Plan and PFMEA documentation and procedures.
• Led, created, and updated DFMEAs for new implants & instruments.
• Ensured documentation is aligned with corporate standards which includes FMEA, DFMEA, Manufacturing Process Improvement / PFMEA, product life cycles, Gage R&Rs.
• Performed gap analysis ofDesignControlQuality System, determined changes required to close gaps, and implement changes.
• Wrote, reviewed, & approved design verification & validation protocols (DOEs, IQ/OQ, PQ).
• Responsible for investigations and implements robust corrective/preventive actions for process/device non-conformances; monitor complaint rates and initiates improvements where required; contribute to Material Review Board; support improvement initiatives.
• Responsible to support Material Review Board (MRB) activities on daily basis and develop strategies to manage inventory disposition.
• Proficient with SolidWorks, PRO-E and CAD
• Support First Article Inspections, In-Process Inspections, Sampling Plans, product/components testing, inspection and acceptance criteria.
• Provided gap assessments, problem statements, containment activities, root cause analysis, corrective action plans for several major findings within the company’squalityaudit (CFR 820.22 & ISO 13485), CAPA (CFR 820.100 & ISO 13485), and NCR (CFR 820.90 & ISO 13485) processes and procedures.
• Facilitate resolution of quality initiatives; containment/root cause/corrective actions, customer issues, etc.
• Approval of all product changes (ECOs, deviations, validations, etc.) to ensure customer requirements and expectations are met, and verification that changes are correctly implemented

Confidential, Salem, VA

Manufacturing Engineer

Responsibilities:

• Optimize processes and manage continuous process improvement projects using Lean and Six Sigma methodology and Design for Manufacturing.
• Work with Manufacturing to identify opportunities for re-design or design of equipment, tools, and fixtures to improve manufacturing processes, and reduce risk and scrap
• Using CAPA, non-conformances, root cause analysis, audit process to resolve manufacturing and compliance issues.
• Resolve complex customer complaints and field performance issues utilizing problem solving tools.
• Write and review protocols, manufacturing instruction, tests, ensuring specifications will produce results that meet end user needs.
• Recommend process changes based on detailed quality analysis and studies.
• Provide quality inputs for new product development project.
• Prepared Engineering Documentation - Drawings, 3D Models, Test Protocols, BOM’ s, etc.
• Created, reviewed, and updated Manufacturing Processes Instruction (MPI) and SOP’s.
• Wrote, reviewed, & approved design verification & validation protocols (DOEs, IQ/OQ, PQ).
• Participate in preparation and ranking of PFMEA’s.
• Author SOP’s and revisions related to Risk Management and its integration with manufacturing process design to convey risk related requirements
• Worked on statistical tools related to experiments, validations, sampling, and testing
• Supported as a quality reviewer/approver for CO’s related to new process development.
• Review specifications, drawings, contracts and supply agreements related to new process development.
• Coordinate corrective actions, maintain report files for NC’s and CAPA’s related to New Process Development and recently transferred processes.
• Developing strategic measuring and statistical techniques for process control (SPC)
• Created and uploaded the corresponding documents, MPI and Source files into Agile, approve the incoming ECOs, MCOs and Deviations.
• CreatedProductRisk Management profile, including Hazard Analysis (ISO 14971), DFMEA, PFMEA, Used FMEA and Control plans of newproductdevelopmentto support R&D Dept.
• Review/Assess Impact Analysis onDesignControls asproductchange.
• Review/ApproveProduct DesignChange Plan (PCR/PCO Process) and conformDesignVerification/Validation activities performed before release to production, ensuring products meet the predefined requirements. Review/Approve Engineering Drawings & Component/ProductDesignSpecifications.