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Richard A. Reinwald
135 Village Lane 203-483-0593
Branford, CT 06405 richardareinwald@gmail.com
PROFILE
Experienced Designer/Draftsman/Document Control Specialist in several medical device and other
manufacturing companies. Dependable, self-motivated professional, extremely attentive to details
and compliance to Quality and Regulatory systems producing quality work on schedule. Working
knowledge of AutoCAD, MasterControl, Outlook, Excel, Word, Mapics, and Dataflo/Dataworks
Software. Familiar with SolidWorks and Inventor Software.
EMPLOYMENT HISTORY
COOPERSURGICAL, INC., Trumbull, CT 2007 - Present
Medical device manufacturer of women’s healthcare products. (Purchased Wallach Surgical
Devices.)
CAD TECHNICIAN / ECN COORDINATOR
 Created and revised CAD files to support all sustaining engineering and new product
Research and Development requirements.
 Processed New Part Number Data Entries in Dataflo/Dataworks Product Management
System including Part Masters, Bills of Material (BOM), Bills of Operation (BOO), and Part
Number Log Book Entries.
 Maintained ECN system and Document Archives for over 30 companies acquisitioned by
CooperSurgical. Processed over 3200 Engineering Change Notices (ECN’s).
 Implemented several major overhauls to ECN System in response to Regulatory Audits and
to prepare for automating procedure in MasterControl Quality System.
 Supported Labeling Department during implementation of Unique Device Identification
(UDI) requirements mandated by the FDA.
WALLACH SURGICAL DEVICES, INC., Orange, CT 1993 - 2007
A privately owned medical device manufacturer of women’s healthcare products.
CAD DRAFTER
 Converted 770 pencil drawings to AutoCAD files.
 Created all Assembly, Detail, and Bill of Material documentation for dozens of New Product
Market Releases.
 Maintained and managed the Engineering Change Notice System and Device Master Records
(DMR’s). Created, Processed, and Implemented over 1800 ECN’s.
 Implemented update of entire ECN Procedure and Forms to excel format for efficiency and
Regulatory Accountability.
LEAD INTERNAL AUDITOR
 Performed regularly scheduled Internal Process Audits and assisted other auditors as needed.
DOCUMENT CONTROL SPECIALIST
 Created and Maintained Technical Files, Manufacturing Flow Charts, and Manufacturing
Instruction (MI) Files for entire Company Product Line.
 Passed all FDA Audits 100% (No Findings)
Richard A. Reinwald Page 2
VALLEYLAB, INC., Stamford, CT 1989 - 1993
A Pfizer owned company manufacturing ultrasonic surgical equipment and accessories.
DESIGNER / DRAFTSMAN
 Provided full support to engineering research and development teams throughout all phases
of design and documentation requirements.
 Implemented both IBMCAD and AutoCAD R12 Software resulting in standardization of
company data formatting.
 Designed prototype clinical housings and repairable sealed endoscopic ultrasonic surgical
aspirator (EUSA) hand-piece for new market introduction.
 Redesigned all aspects of initial console layout from outside consulting firm, drastically
reducing production costs, increasing efficiency of manufacturability and reducing time to
market.
 Created entire bill of material structures and various procedures and source control
specifications for above mentioned projects.
OTHER DRAFTING EXPERIENCE
TEMTEK, INC., Milford, CT | DRAFTSMAN | 1989
COROMETRICS MEDICAL SYSTEMS, INC., Wallingford, CT | DRAFTSMAN |1982 - 1988
An American Home Products owned company manufacturing fetal and neo-natal monitors and
accessories.
NORWALK FABRICATORS, INC., | Branford, CT | DRAFTSMAN | 1981
Manufacturer of pressure vessels, storage tanks, boilers and other large welded fabrications.
HARCO LABORATORIES, INC.| Branford, CT | DRAFTSMAN | 1979 – 1980
Manufacturer of thermocouples, pressure probes, and electrical harnesses for aircraft engines.
FIRE LITE ALARM, INC. | New Haven, CT | DRAFTSMAN | 1977 - 1978
EDUCATION
Eli Whitney Vocational High School, Hamden, CT | Honor Graduate | Major: Machine Drafting
SPECIALIZED TRAINING
AutoCAD Release 12 through Inventor 11
SolidWorks Essentials 2016
Geometric Tolerancing (ASME Y 14.5-2009)
CAPA Pathwise
Design for Assembly
IS0-13485:2016 Introduction Courses
MRP II (Valleylab achieved Class A status)
Good Manufacturing Practices (GMP)

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Experienced Medical Device Designer and Quality Professional

  • 1. Richard A. Reinwald 135 Village Lane 203-483-0593 Branford, CT 06405 richardareinwald@gmail.com PROFILE Experienced Designer/Draftsman/Document Control Specialist in several medical device and other manufacturing companies. Dependable, self-motivated professional, extremely attentive to details and compliance to Quality and Regulatory systems producing quality work on schedule. Working knowledge of AutoCAD, MasterControl, Outlook, Excel, Word, Mapics, and Dataflo/Dataworks Software. Familiar with SolidWorks and Inventor Software. EMPLOYMENT HISTORY COOPERSURGICAL, INC., Trumbull, CT 2007 - Present Medical device manufacturer of women’s healthcare products. (Purchased Wallach Surgical Devices.) CAD TECHNICIAN / ECN COORDINATOR  Created and revised CAD files to support all sustaining engineering and new product Research and Development requirements.  Processed New Part Number Data Entries in Dataflo/Dataworks Product Management System including Part Masters, Bills of Material (BOM), Bills of Operation (BOO), and Part Number Log Book Entries.  Maintained ECN system and Document Archives for over 30 companies acquisitioned by CooperSurgical. Processed over 3200 Engineering Change Notices (ECN’s).  Implemented several major overhauls to ECN System in response to Regulatory Audits and to prepare for automating procedure in MasterControl Quality System.  Supported Labeling Department during implementation of Unique Device Identification (UDI) requirements mandated by the FDA. WALLACH SURGICAL DEVICES, INC., Orange, CT 1993 - 2007 A privately owned medical device manufacturer of women’s healthcare products. CAD DRAFTER  Converted 770 pencil drawings to AutoCAD files.  Created all Assembly, Detail, and Bill of Material documentation for dozens of New Product Market Releases.  Maintained and managed the Engineering Change Notice System and Device Master Records (DMR’s). Created, Processed, and Implemented over 1800 ECN’s.  Implemented update of entire ECN Procedure and Forms to excel format for efficiency and Regulatory Accountability. LEAD INTERNAL AUDITOR  Performed regularly scheduled Internal Process Audits and assisted other auditors as needed. DOCUMENT CONTROL SPECIALIST  Created and Maintained Technical Files, Manufacturing Flow Charts, and Manufacturing Instruction (MI) Files for entire Company Product Line.  Passed all FDA Audits 100% (No Findings)
  • 2. Richard A. Reinwald Page 2 VALLEYLAB, INC., Stamford, CT 1989 - 1993 A Pfizer owned company manufacturing ultrasonic surgical equipment and accessories. DESIGNER / DRAFTSMAN  Provided full support to engineering research and development teams throughout all phases of design and documentation requirements.  Implemented both IBMCAD and AutoCAD R12 Software resulting in standardization of company data formatting.  Designed prototype clinical housings and repairable sealed endoscopic ultrasonic surgical aspirator (EUSA) hand-piece for new market introduction.  Redesigned all aspects of initial console layout from outside consulting firm, drastically reducing production costs, increasing efficiency of manufacturability and reducing time to market.  Created entire bill of material structures and various procedures and source control specifications for above mentioned projects. OTHER DRAFTING EXPERIENCE TEMTEK, INC., Milford, CT | DRAFTSMAN | 1989 COROMETRICS MEDICAL SYSTEMS, INC., Wallingford, CT | DRAFTSMAN |1982 - 1988 An American Home Products owned company manufacturing fetal and neo-natal monitors and accessories. NORWALK FABRICATORS, INC., | Branford, CT | DRAFTSMAN | 1981 Manufacturer of pressure vessels, storage tanks, boilers and other large welded fabrications. HARCO LABORATORIES, INC.| Branford, CT | DRAFTSMAN | 1979 – 1980 Manufacturer of thermocouples, pressure probes, and electrical harnesses for aircraft engines. FIRE LITE ALARM, INC. | New Haven, CT | DRAFTSMAN | 1977 - 1978 EDUCATION Eli Whitney Vocational High School, Hamden, CT | Honor Graduate | Major: Machine Drafting SPECIALIZED TRAINING AutoCAD Release 12 through Inventor 11 SolidWorks Essentials 2016 Geometric Tolerancing (ASME Y 14.5-2009) CAPA Pathwise Design for Assembly IS0-13485:2016 Introduction Courses MRP II (Valleylab achieved Class A status) Good Manufacturing Practices (GMP)