Manufacturing Engineer Project Management

Roger A. Hodder, PMP, MCP

Phone: 303-***-**** ***********@*****.***

Cell phone: 715-***-****

Engineering / Project Management

Senior Manager with extensive experience in delivering improved productivity, cost to market improvements, sustainability, vendor selection/quality assurance, staff management, project management, product introduction and issue resolution.

•Core Competences

Management of NPI (New Product Introduction) Contracts – Pricing – RFQ processing

Project Planning and Management P&L Management

Customer and Vendor Relationships Six Sigma–Green Belt- Quality - SPC

Production Management / Inventory Control ERP – MRP systems

Engineering/ Manufacturing/Quality Procurement/Supply Chain

Lean Manufacturing Concepts and Implementation Discrete / Repetitive Manufacturing

CAPA resolution and Quality improvements Project Presentations

Production Flows for GMP Protocols and FDA documentation

Professional Experience

Senior R & D Engineer Nov. 2016 – Apr. 2017

Search Solutions (ConvaTec) – contractor – 6 month contract

Finalized two major MIPs (margin improvement program) Valued at plus $1,000,000 annual savings for each program

Authored required FDA documentation – CCR, MQP-DHF-Protocols

Authored documentation and project managed Deviation Request

Conducted and documented new product verification testing

Authored new product validation protocols and test reports for DHFs

Manufacturing Engineer Sept. 2015 – March 2016

Oxford Global (Medtronic) - contractor - 6 month contract

•Up graded a 20 year old plastic extruder system to produce a critical component of a Class II medical device – increased Cpk on the diameter from 1.0 to over 1.40

•Provided engineering support to upgrade an entire automated assembly line to achieve production of 1 million units per week – 22% production increase

•Demonstrated numerous Gmp process improvements / sustaining engineering projects in manufacturing and documentation processes

•Provided process flows and manufacturability studies for NPI.

Page 2 Roger A. Hodder

Manufacturing Engineer Jan. 2015 – Jun.2015

Oxford Global (Medela) – contractor – 6 month contract

•Project Managed a production improvement project in a Class II medical device company – clean room production – 26 different SKU’s with over 96 components

•Extensive review of the current production processes, noting numerous non-value added operations, non-effective material handling and component storage

•Provided a detailed presentation to the major stake holders which outlined process flow improvements, material handling improvements, product content improvements, automation, operator assignment improvements and operational improvements which would yield a 23 % productivity improvement.

•Provided a scale production floor lay out which depicted the proposed process flow and used 3-D printer models of operators and work stations

•NPI process flows and cost to manufacture

Manufacturing Engineer March 2014 – Sept. 2014

Oxford Global (Phillipsmedisize) – contractor – 6 month contract

•Conduct IQ, OQ, PQ verification for FDA approval on a new class III medical device – class 7 cleanroom – injection molded LSR

•Review current processes and revise as needed to improve flow and practice Lean Manufacturing. Provide revisions to assure GMP and PDP

•Develop tooling, fixtures and vision systems to assist in manufacturing.

•Wrote work instructions and reviewed quality processes for Six Sigma improvements.

•Wrote protocols for FDA submission.

•NPI manufacturability studies and process flow

Manufacturing Engineer June 2010- April 2013 Accellent, Arvada, CO

•Directed customer quotation requests, achieving a very high ‘win’ ratio.

•Initiated formal quote review meetings with design and manufacturing engineers

•Designed, installed and conducted IQ, OQ, PQ verification for FDA approval on new medical device products.

•Conducted sustain engineering studies and projects to assure GMP and Lean Manufacturing objectives. Recently completed a $5,000,000 device project ahead of schedule and under budgeted cost.

•Conducted CAPA investigations and provided Quality improvements on existing products.

•Designed/directed fixtures for NPI manufacturing and Quality assurance

Page 3 Roger A. Hodder

Manufacturing Manager Feb2007 – May 2010

nSpire Health, Louisville, CO

•Managed 30 direct reports in the production of discrete medical equipment.

•Introduced the practice of cell manufacturing which provided 50% improved lead time and reduced cost to market.

•Implemented the use of product process sheets which provided compliance to ISO 13485 and GMP.

•Established a service part depot within the manufacturing area which provided improved customer equipment down time. Class II respiratory test equipment.

•Introduced a new respiratory test chamber which had been produced overseas.

Education

Yellow and Green Belt Six Sigma Certification – Aveta

Bachelor of Science - Business Management - University of Detroit

Associates Degree - Mechanical Engineering - Eastern Michigan University

MCP - Microsoft Certified Professional

PMP - Project Management Professional - Villanova University

Advanced studies - SPC, Stress, Auto CAD, GDT

Military

Honorable Discharged Officer having been awarded two campaign ribbons and the Bronze Star.

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