SUMMARY:

• Experienced Quality Engineering, Manufacturing, and Process Validation professional with strong medical device background. Key qualifications include:
• Non - conformance investigation
• In-depth understanding of medical device regulations practices.
• Good knowledge of medical device regulation (ISO 13485, 21 CFR 820) and risk management (ISO 14971) throughout career.
• Clean room validation
• Test method validation
• Knowledge of design control, design transfer
• Plastic Injection molds machine and air extruders.
• Over 15 year’s medical device and DHR experience.
• Working knowledge of FMEA.
• Working knowledge of air/wire plastic extrusion, and injection molders
• Proficient in statistical, quality and continuous improvement methods and Tools
• Good working knowledge of Quality Control and cGMP
• Angio-plastics heat sealing processes, balloon pleat/ fold and crimp process.
• Knowledge and Experience with material process and testing.
• Design, troubleshooting and presentation skills
• Change control to revise and implement SOPs, Work Instructions, Forms, etc. Tracking of documents to implementation.
• Experience with product assembly and Manufacturing Methods/equipment (E.G. Ultrasonic Welders, Crimping, Molding, MIM, Leak Testers, Machine Controls and Vision Systems.
• Protocol/report writing, IQ/OQ/PQ, Master Validation plan, Risk Management, Document revisions.
• Material knowledge includes titanium, stainless steel, and angio-plastics.
• Have applied lean manufacturing principles throughout career.
• Knowledge of GD&T.

TECHNICAL SKILLS:

Computer Skills: Equipment maintenance Maximo, MP2 Experience using MINITAB, SIX SIGMA, DOE, GR&R, CAPA, DMAIC Demonstrated proficiency in standard office software, including Word, Excel, and PowerPoint. Asset Management: SAP, Agile, PDM, Master Control, JD Edwards

PROFESSIONAL EXPERIENCE:

Confidential, Merrimack, New Hampshire

Manufacturing Engineer Consultant

Responsibilities:

• Monitor shift activity during Thoracic drains production.
• Communicate with the quality department to react to any daily production issues and help develop customer feedback on any concerns.
• Support manufacturing personnel in identifying root cause and developing corrective/preventative actions associated with both customer and internal complaints.
• Continuously monitor and react to long term production costs and efficiency trends
• Provided daily shift performance data.
• Investigates equipment breakdown and non-conformance.
• Performed NCR investigation.

Confidential, Glens Falls, New York

Validation and Quality Engineering Consultant

Responsibilities:

• Contributed to major projects involving design transfer and process development of equipment, methods, and tooling required for the production medical devices.
• Audited work instructions for discrepancies with work performed. Execute document change where necessary.
• Process validations revision to identify gaps to internal and external requirements
• Participating in CAPA (Corrective and Preventive Action) projects.
• Contributing to cross - functional teams that enhance project implementation and process improvement, which includes application of FMEA and risk management assessment.
• Supported new product development through using quality tools and manufacturing engineering approaches.
• Generation of report and execution with respect to Quality System Procedures, SOPs, and Instructions.

Confidential, Hudson, New Hampshire

Manufacturing/Validation Engineer (Remediation)

Responsibilities:

• Work with Engineering department cross - functional groups to identify process validation needs.
• Monitor balloon catheter production, analyze data and prepare strategies to improve yields using Minitab and Excel where necessary.
• NCR/NCMR, CAPA, and ECO processing
• Identification of gaps in process validation remediation.
• Use of quality tools to resolve production issues.
• Working knowledge of Minitab for statistical analysis and risk management assessments.
• Supported with the creation of work instructions and SOPs.
• Process validation protocol and report writing
• Assisted in meeting departmental goals, and in special projects as needed.
• Validating medical device manufacturing processes (IQ, OQ, PQ,); applying FMEA methodology.
• Application of lean manufacturing principles

Confidential, Lakeland, Florida

Validation Engineer - Medical Device Reprocessing (Remediation)

Responsibilities:

• Equipment validation, including design control.
• Controlled (clean) room qualification
• Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ,); apply FMEA methodsapplication of lean manufacturing principles.
• Supported PFMECAs, normality assessment, sampling plans and capability assessment.

Confidential, Miami, Florida

Quality Engineer (Remediation)

Responsibilities:

• Reviewed of measurement Instruction documents for Zimmer Orthopedic.
• Geometric Dimensioning and tolerances (GD&T).

Confidential, Miami, Florida

Process Engineering Technician

Responsibilities:

• Analysis of clean - room data trend for pressure temperature and humidity.
• Provide day-to-day manufacturing support (lean principles), evaluating and addressing production concerns and problems throughtroubleshooting of components, tooling, fixtures and processes.
• Work with drafting and documentation departments to create all required documents (manufacturing processes, drawings, protocols, reports, etc.).
• Updated in ISO, Quality Assurance and FDA regulation.
• Participate in Environmental Health and Safety (EHS) related actions, to improve workplace safety.
• Conducted walk through audits to ensure GMP adherence.

Confidential, Miami Lakes, Florida.

Principal Validation Engineer Technician

Responsibilities:

• Generation of Test Method Validation and Process Validation protocol.
• Wrote injection mold PM procedure for the bi - weekly replacement of injection screw.
• Performed bi-weekly preventive maintenance of injection mold machine (replacement of injection with cleaned one that was immersed in fluidized sand bath.
• Authored SOPs and work instructions for lean manufacturing processes.
• Deal with qualified professional in the electronics, mechanical, production, quality, and bio-medical disciplines.
• Have design responsibilities at an electrical, mechanical, sub-assembly level with the abilities to recommend changes in procedure, process and program.
• Working knowledge of Minitab for statistical analysis; utilized for risk management assessment.
• Provide major assistance in releasing product to production including documentation releases, production personnel, production problem troubleshooting.
• Responsible for ensuring personal and company compliance with all State Local and Federal regulations policies and procedures for Environmental, Health and Safety compliance