Profile Details

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Hire David P.

United States

USD 170 /hr

Medical Device Commercialization and Manufacturing Automation Consultant in a Regulated Environment

Profile Summary

I am a process and product development commercialization consultant and project manager with an automation and mechanical engineering background having 15 years of experience with process and product development for orthopedic products, parenteral products, auto-injectors and disposable injector pens for different markets in an international environment and 27 years of experience as a manager and engineer. Products that I have worked on have over 1 billion dollars in annual sales. I have worked on 6 major medical device programs for five different companies. I was technically responsible for leading the manufacturing and process development to produce medical devices and the translation of those processes into commercial manufacturing capacity through the launch of the product. I have lead the early commercialization work for orthopedic products, parenteral products, N95 Protective masks, auto-injectors and injector pens working with the team to establish process specifications and to provide the Design for Manufacturing and Design for Assembly analysis and feedback while working on the design team to refine the product design for manufacturing. This work involved leading the development of the FMEAs for the product and translating the results into project planning, user requirements and control plans for the manufacturing site. This work included leading th team to develop equipment specifications, guiding vendor selection for equipment delivery and managing the equipment delivery effort though final qualification at the customer site. My work has included high and low volume production and scaling up processes from manual to fully automated, high- speed assembly in a regulated environment.

Subject Matter Expertise

• ★ Manufacturing
• ★ Medical Device Development
• ★ Project Management
• ☆ Biology/Life Sciences
• ☆ Biomedical Engineering
• ☆ Lean Manufacturing
• ☆ Automation
• ☆ Engineering Design
• ☆ Leadership
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Product Development
• ☆ 3D Printing/Additive Manufacturing
• ☆ Risk Management

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Concept Development, Prototyping

Work Experience

Managing Principal Consultant

Synch Engineering and Automation / Automation Dynamics

January 2014 - Present

Founding partner

Adjutant Solutions Group

June 2005 - June 2014

Program Manager

Invensys

June 2003 - June 2005

Automation Technical Consultant and Program Manager

Rockwell Automation

January 1997 - January 2003

Education

Mechanical Engineering

Purdue University

January 1984 - May 1993

Certifications

• Rockwell Automation Software Development License

  Rockwell Automation

  October 2021 - Present

• Project Management Professional

  Electonic Data Systems

  July 1996 - Present

• Product Development Management

  Electronic Data Systems

  August 1995 - Present

• CGMP Practices

  Eli Lilly and Company / Amylin

  June 2005 - April 2014

• ISO 13485 Medical Device Quality Management Systems

  Eli Lilly and Company

  January 2011 - January 2014

• ISO 14971 Risk Management

  Eli Lilly and Company

  April 2009 - January 2014

• Invensys Program and Project Management

  Project Management Institute

  April 2004 - April 2009

• Rockwell Automation Instructor Certification

  Rockwell Automation

  January 1998 - June 2003