Richard Reinwald has over 30 years of experience as a designer, draftsman, and document control specialist for various medical device companies. He has extensive experience with CAD software such as AutoCAD, SolidWorks, and Inventor, as well as document control systems including MasterControl, Dataflo, and Dataworks. His resume highlights his roles supporting research and development, managing engineering change notices and document archives, and ensuring regulatory compliance.
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)