Engineer Resume

SUMMARY:

Strong experience in in the Medical Device industry (mechanical /Product engineering). Medical product FDA compliance with CRF21, ISO, and Class 11 devices. Six Sigma as well as Lean Six Sigma trained. CAPA Engineering investigations and writing. ASQ Auditor trained while serving as Manager of Documentation and Design Control. Injection molded part design, mechanical design, and Solidworks trained and experienced. Project management as well as a Masters degree in Management. Technical Protocol writer as req’d per position for SOP, OP and manual writing procedures. Project Manager,CAPA team mechanical input person. Quantiles Validation and Verification trained and compliance procedure trained.

PROFESSIONAL EXPERIENCE:

Confidential

Engineer

Responsibilities:

Responsible for creation of NGT Design Verification reports relative to Ireland facility testing of Parkinson’s disease apparatus.
I was brought in as consultant due to my experience on the 1st gen. of this product.
As well I worked with Solidworks 2016 for product development of the packaging and labeling related to the device.

Confidential

Principal Engineer

Responsibilities:

Responsible for new respiratory anesthesia product development engineering assignments relative to many engineering disicplines.
Writing of protocols and new specifications of product release for Puerto Rico incoming inspection as well as Packacging labeling and drawings.
Geo - dimensioning determinations.
Use of Solidworks, Pro-E and AutoCad software for design related activities.

Confidential

Validation Engineer

Responsibilities:

Protocol writer and development of new products associated with Parkinson's Disease devices. Responsibilities included Lab Studies, Investigation of Quality Complaints, Design Change Control and CAD Solidworks
Design when needed. Patent Part drawings with associated Design & documentation of Combination Products.

Confidential, McGaw Park, IL

QUALITY ENGINEER

Responsibilities:

Responsible for Quality analysis issues in relation to Renal ‘HomeChoice Unit’, Continuous Cyclic Peritoneal Dialysis unit. All hardware reported quality issues, including complaints.
Use of ‘Trackwise’ and Pilgirm ‘SmartSolve’ software in order investigate, determine coded problem and signoff on complaint corrective actions as the last management prior to FDA review.
ASQC, QE training.Protocol witing and adherence.

Confidential, San Antonio,Texas

CAPA ENGINEER (QA - Compliance- Validation)

Responsibilities:

Investigative support in relation to Corporate Engineering Systems (CAPA, Validation/Verification, Risk Management and Risk Analysis) per FDA regulated guidelines.
Protocol adherence and writing.

Confidential, Lake Forest, IL

DEVICE DESIGN CONTROL ENGINEER (QA - Compliance- Validation)

Responsibilities:

Responsible for providing Project Management support in relation to Corporate Quality Systems.
Application of Design Controls for (CAPA, Validation/Verification, Risk Management and Risk Analysis) per FDA regulated guidelines.
Analysis of various mechanical systems including machineries for medical product industry as well as I.V. solution pumps.

Confidential, Wood Dale, IL

PRODUCT DESIGN ENGINEER

Responsibilities:

Responsible for mechanical sustaining engineering assignments in Medical/Dental Medical Imaging Engineering.
Design for advanced product development using Solidworks CAD and AutoCAD in relation to injection molded parts.
CAPA team membership in relation to compliance.
Quality Engineering analysis in relation to QSR, CMDR, and ISO 13485 as well as FEA, FMEA and Six Sigma training

Confidential, IL

SENIOR ENGINEER

Responsibilities:

Responsible for mechanical activities involving I.V. solution pumps in particular ‘Colleague’ pump.
Use of SolidWorks 2007 for design modeling and detailing using GD &T.
The use of Cosmos FEA software in relation to FDA compliance decree to solve problems.
Also CAPA member Mechanical part consultant.
Plastic and sheet metals investigation for products as well as advanced part modeling in SolidWorks CAD.
Vendor and internal customer daily contact and followup. Technical writing as req’d.

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