Strong Medical Device background with 30 years of leadership and management experience covering engineering, quality, and business development. Seeking a role as department or program director in area of New Product Development, Sustainment Engineering, Business integration, Quality Assurance, Regulatory Affairs, or Marketing. Greatest strength is taking complex situations and distilling them into a plan of action followed by execution ensuring results. Ready for a new and challenging leadership role in a reputable and competitive company.
Leadership (Vision, Mission, People & Programs)
Management (People, Budgets, Schedules)
New Product Development
Quality Assurance Methodologies
FDA/Notified Body Audits
Market and Customer Analysis
Quality Management Systems Development
integration of a new product platform worth $40 million in annual revenue from acquisition
Directed efforts that improved the ERP system reducing over 100 procedures down to 12 procedures.
Directed the creation and execution of Risk Management and Change Management procedures lifting an FDA warning letter.
Directed the launch of 4 platform product lines turning around a stalled business unit growing to $100 million in 2015 averaging over 20% growth per year.
Managed new product development launching new products and driving revenue growth.
Managed sustainment engineering driving out
costs raising profits.
Lead new product development projects achieving cost, quality, and timing metrics.
new products yielding competitive edge through innovation.
Director Business Integration, 02/2016 to CurrentStryker Instruments － Kalamazoo, MI
Oversee the integration of products procured through acquisition or merger into the Stryker quality management system. Verify sound design and manufacturing process files. Improve product designs and manufacturing processes. Develop line extension products. Create design history file and device master records in compliance with internal requirements and external regulations. Launching first product platform in Q1 2017 with first year sales totaling $40,000,000.
Director Quality Assurance - ERP Transformation, 10/2014 to 02/2016Stryker Instruments － Kalamazoo, MITransformed the Quality System from a legacy Enterprise Resource Planning (ERP) solution to a best in class state of the art ERP solution. Reduced over 100 processes to 12 processes. Lead cross functional teams of business work stream managers and process owners in transforming their business processes. Developed new governance model, role definitions, and quality management system document structure. Results improve the efficiency and effectiveness of our business and our customer's experience.
Director of Quality - Risk and Change Management Departments, 01/2011 to 10/2014Stryker Instruments － Kalamazoo, MIDeveloped, implemented, trained, and executed Risk Management and Change Management procedures to ensure compliance with ever changing regulations. Successfully transformed both the Risk Management and Change Management programs at Stryker Instruments as required by ISO 14971 and FDA's Code of Federal Regulations. Provided immediate impact by lifting an FDA warning letter associated with legacy risk management programs. Improved product safety. Improved legal stance relative to liability concerns. Reduced considerable cost in execution of change orders related to design control. Made real and lasting impact through transformation of both process and culture.
Director Research and Development - Interventional Spine Business, 06/2007 to 12/2010Stryker Instruments － Kalamazoo, MI
Took over a stalled business unit's research and development department. No product launches occurred for 2 years prior to assignment. Launched 4 world class product platforms over 3 years. Platforms include Multi-Lesion RF Generator for nerve ablation, implantable cements for Vertebroplasty, implantable cement mix and delivery devices, and balloon tamps for augmented Vertebroplasty. Success leveraged market analysis, sales force interaction, intellectual property assessment, innovative design, and cross functional team project management. This business unit has grown 30% to $130,000,000 in annual sales this year.
Sr. Manager Research and Development - OR Products, 03/2003 to 06/2007Stryker Instruments － Kalamazoo, MI
Managed Operating Room (OR) Products new product development department. Launched 4 product platforms and several line extensions during this assignment. The platforms are as follows:
1. Sterishield T5 Personal Protection System.
2. Revolution Implantable Cement Mixing and Delivery System.
3. Pain Pump Pain Management System.
4. Neptune 1 Waste Management System.
Manager - Product Engineering Department, 04/1996 to 03/2003Stryker Instruments － Kalamazoo, MIManaged sustainment engineering for existing products. Delivered highly effective results in the following areas of work: Production Recovery, Line Extensions, Quality Improvement, Cost Reduction, Compliance to Changing Regulations. The department included engineering, document control, change management, drafting, literature and labeling, and the quality management system.
Design Engineering and Project Management, 08/1987 to 03/1996Zimmer Patient Care － Dover, OHDesign Engineer/Sr. Design Engineer for various product platforms including: Irrigation, Cement, Blood Drainage and Reinfusion, Burn Care, Tourniquet, Wound Drainage, and Cold Therapy Care. Promoted to Project Manager, then Senior Project Manager for these same platforms.
MBA:BusinessUniversity of Akron － Akron, OH, USABusiness administration with emphasis on International Marketing.
Bachelor of Science:Chemical EngineeringUniversity of Akron － Akron, OH, USA
Focus on Polymer Science, Polymer Engineering, Manufacturing with Polymers.
Officer O1 - O3, 06/1994 to 07/2007United States Army National Guard
Second Lieutenant Air Defense Artillery - Ohio. Tactical Control Officer for Hawk Missile System. Jun 1994 to Jun 1997. Received awards, medals, commendations for White Sands training exercise.
First Lieutenant Field Artillery - Michigan. Fire Direction Control Officer promoted to Battery Executive Officer for M109 155mm self-propelled howitzer. Received awards, medals, commendations for OP4 Operations at National Training Center war games. Jun 1997 to Jun 2000.
Captain Field Artillery - Michigan. Battery Commander then Acting Battalion S3 Operations Officer. Deployed to Guantanamo Bay Cuba Oct 2002 - Oct 2003. Commanded 100 soldiers executing detainee operations as part of Operation Enduring Freedom. Jun 2000 - Jul 2007. Received awards, medals, commendations for deployment.
Retired with 25 years honorable service.
Enlisted E1 - E6, 05/1982 to 06/1994United States Army National Guard － Dover, OH
Transportation unit. Promoted up through E5 (Sergeant). Deployed to Persian Gulf War August 1990 – October 1991. Earned numerous awards, medals, commendations.
Enlisted in Officer Candidate School in 1992 as E6. Federally commissioned as US Army Officer 1993. Received honor graduate.
Graduated Officer Basic Course 1994. Received APFT, Leadership, and Honor Graduate awards.