SUMMARY:

• Strong experience in in the Medical Device industry (mechanical /Product engineering).
• Medical product Confidential 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, G D & T and Solidworks CAD 1997 - 2015 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 while @ Confidential .
• While working as a Principal Engineer I dealt with Packaging Engineering as well as labeling and CAD Dieline creation using AutoCad and Solidworks.

PROFESSIONAL EXPERIENCE:

Confidential

Engineer, Madison, WI

Responsibilities:

• Primary work will be for Administration System Qualification (ASQ) for drug delivery devices.
• Secondary area of focus will be in supporting multiple medical device change control products for commercial vial reconstitution products.
• The Position includes global collaboration with technical staff, and direction and supervision of a technical report to meet established commitments.
• The position includes writing protocols, conducting engineering laboratory testing, analysis of data and writing of reports.

Confidential

Engineer

Responsibilities:

• Responsible for creation of NGT Design Verification reports relative to Ireland facility testing of Parkinson’s disease apparatus ( Confidential ).
• I was brought in as consultant due to my experience on the 1 st gen. of this product.
• As well I worked with CAD 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 Packaging labels and drawings.
• Geo-dimensioning determinations.
• Use of 2016 Solidworks, 2016 Pro-E and AutoCad software for design related activities.

Confidential

Validation Engineer (Medical Product 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 2014 Design when needed.
• Patent Part drawings with associated Design & documentation of Combination Products.
• TMV, Test Method Validation.

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 Confidential 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 Confidential regulated guidelines.Protocol adherence and writing.

Confidential . Lake Forest,IL C

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 Confidential 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, Confidential 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 Confidential 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.

Confidential

PRODUCT DEVELOPMENT ENGINEER

Responsibilities:

• Product Development Engineering assignments for precision Orthopedic Surgical Devices.
• Use of advanced SolidWorks for design and development of precision surgical products (GD&T) as well as AutoCad softwares.
• Confidential analysis involvement with various product groups.
• Project management 'start to finish' for Spinal Surgical devices.
• Lean Six Sigma Certification and CAPA team membership.
• Plastic and Surgical grade metals investigation for products.
• Advanced part modeling in SolidWorks CAD using COSMOS for stress analysis.
• Vendor and internal customer daily contact and followup - Medtronics, Aesculap, Blackstone and Abbott Spine.

Confidential, Abbott Park, IL

SENIOR CAD DESIGNER/ ENGINEER

Responsibilities:

• Responsible for CAD mechanical and product design in relation to SAMS machines and fixturing with use of AutoCad and Solid Works CAD software.
• Validation and Verification of in house medical product machineries.
• Interface with outside vendors and company shop persons for fabrication.
• Current geometric tolerancing and dimensioning (GD&T) Technical writing.

Confidential

CAD DESIGNER /ENGINEER

Responsibilities:

• CAD Designer working for Confidential compliance decree related issues in relation to ADD manufacturing equipment drawings.
• Designated as Drawing Control (DCA) person (initiator, checker, and approver) of equipment drawings.
• Validation and Verification of machinery for compliance decree related activities.
• Contributed to creation of OP502B ‘Creation and Control of Equipment drawings’ and the conversion of non controlled drawing files to controlled types.
• Technical writing as req’d. per position.

Confidential

MANAGER of DOCUMENTATION AND DESIGN CONTROL

Responsibilities:

• Direct report to VP of R&D. Responsible for managing documentation control group which consisted of 4 individuals which supported the whole division of Surgitek medical products.
• Other responsibilities include: CAD upgrade and administration (AutoCad #14) monitoring of daily doc. operations.
• Also support of Design Control in relation to all new products from R&D group. CFR and GMP compliance and corporate auditing reponsibilities.
• As Manager I was responsible for all training of QSR, CMDR, ISO 13485 and the MDD for all appropriate personnel as necessary.
• I was the chairperson for all Design Review related activities for Class 1 and Class 11 surgical medical products for all Design phases and I was responsible for the DHF and DMF files. Achieved ISO9001 certification as manager and designed new ECR/ECN company distribution system for engineering documentation.
• ASQC Certified as Auditor and. Six Sigma Certified. Technical writing as req’d. per position. Auditing and protocol responsibilites.

Confidential, Round Lake, IL

CAD APPLICATIONS SPECIALIST

Responsibilities:

• Responsibilities include: Drawings created with "AutoCAD" Release 14. Drawing maintenance and new drafting projects for Galaxy I.V. Bag Machine (mechanical), plant engineering drawings (piping and isometric piping), building (architectural) and critical systems (CWR) updates and maintenance. Design and drafting of small mechanisms.

Confidential, Gurnee, IL

CAD DESIGNER

Responsibilities:

• Responsible for Product and Mechanical Design/Drafting drawings created with "AutoCAD" software versions 12, 11 and 10.
• Electromechanical products.
• The ability to create 2D and 3D solid model drawings of moderately complex to complex parts.
• Develop layouts, prepare complex engineering drawings for release to production areas.
• PCB and electrical schematic drawing revision as required. 3D solid modeling and Geotol detailing of die cast and investment cast parts.
• Use of softwares include: Autocad "AME" solid modeling, Automanager, MS DOS Editors for AutoLisp programs, Fox Base, Mapics and windows.
• Products include: Motion control devices, trackballs (for medical instruments) and digital counters.