SUMMARY:

• Results driven leader capable of making critical decisions with positive outcomes for multi - million dollar initiatives. With a successful track record of commercialization, remediation, and organizational development, able to formulate complex programs with specific goals, while building up and leading the team to achieve them. Breaks down functional and cultural barriers to achieve alignment and organizational effectiveness, while earning the respect and trust from all levels of the company.
• Project and Program Management
• New Product Development and Manufacturing Management
• Systems and Requirements Engineering
• Technical Marketing Analyst
• Quality and Test Engineering
• Operations Management
• Risk Management and Controls
• Quality System Deployment and Sustainability
• Design for Manufacturability (DFM) and Lean Manufacturing Expert
• Med Device Start-up Support & Due Diligence

TECHNICAL SKILLS:

COMPUTER SKILLS: MS Office, SAP, ENOVIA, Access, Adobe Illustrator, Minitab, Basic Solidworks CAD, Weibull WinSmith Reliability Software, SharePoint and Agile.

PROFESSIONAL EXPERIENCE:

Confidential - Louisville, KY

Senior Engineer, Technical Operations

Responsibilities:

• Develop CFR 820 and ISO 14971 compliant Quality System.
• Developed all technical deliverables for a combination device injection pen and infusion pump for APOKYN drug.
• Manage all Medical Device and CFR 820 compliance activities for the company.
• Manage pharmaceutical stability testing.

Confidential - Louisville, KY

Director of Quality and Regulatory Affairs

Responsibilities:

• Develop FDA based Quality System (from ground up). Audited by BSI.
• Support quality and regulatory functions on the Electrotek EEG product development. FDA and MDD submissions.
• Aid in the setup of in-house manufacturing area and supporting production documentation.
• Consult on business logistics, in-house manufacturing, infrastructure and product development.
• Conduct Design Validation and Human Factors testing.
• Responsible for directing product development activities with external design service company.

Confidential - Lake Forest, IL

Principle Systems Engineer

Responsibilities:

• Responsible for leading remediation efforts on four pump systems, syringe and cartridge Rx combo platforms.
• Responsible for developing and remediating all consumable product labeling and content.
• Responsible for implementing current system engineering processes, tools, and work procedures.
• Managing the Requirement Analyst Group (5) and offshore (India) resources (14-25) to support label changes.
• Develop VOC, system architecture, use cases and risk management (HA, DFMEA) documentation.
• Conduct requirement management and analysis using Rational DOORs RM tool. Using JIRA tool for CMP.

Confidential - Jeffersonville, IN

Program Director/Program Manager

Responsibilities:

• Responsible for cross-functional engineering teams (7-22) which specialize in leading edge innovation and complex R&D programs (e.g. drainage catheter, articulating guide catheter, mitral valve repair, uterus slings/mesh, neuro guide catheter portfolio).
• Oversight of all aspects of the product development portfolio which consisted of six major programs at one time (in all stages of the development and manufacturing life cycle). Setup PMO.
• Developed complex project plans and strategies. Monitor and control. Highly iterative (e.g. SCRUM like).
• Facilitated and supported monthly client program governance meetings from the Board and C-level.
• Responsible for internal (operations forecast; capital) and external financials (budget), and gross margin targets.
• Implemented company initiatives such as customer service, interactive plant tours, technical cross- program, problem solving, DFM formal practices and ProChain project management/methodology.
• Responsible for working closely with Business Development to competitively quote and capture new opportunities.

Confidential- Indianapolis, IN

Technical Project Leader/Systems Engineer

Responsibilities:

• Responsible for Technical Leadership and Systems Engineering for a wireless glucose meter project (i-phone like).
• Lead a cross functional 35+ person engineering team with a global system engineering counterpart.
• Managed a +$7 million annual budget.
• Aligned the marketing, business and engineering teams to elicit and elaborate portfolio, product and project visions.
• Managed requirement development (RequsitePro), checked requirement wording quality (SmartChecker), analyzed traceability, developed use cases (RavenFlow), developed user interface menu maps and screen specs (Visio), and developed system of systems structural architecture (Enterprise Architect).
• Developed strategic and tactical project schedules using critical chain (MS Project with ProChain add-ons).
• Lead system and firmware Change Control Boards (Rational ClearQuest). Local and international facilitation.
• Performed model based and pattern based system analysis (reuse/product line methodologies).
• Developed Risk Management and linked to requirements in RM tool (HA/DFMEA/PFMEA; Dyadem FMEA sw).

Confidential - Indianapolis, IN

PD Program Manager/Manufacturing Engineering Manager

Responsibilities:

• Responsible for Systems Project Management for major R&D product life-cycle programs. Projects ranged from $250k to $3.5M. Primary focus on FDA Class II & III devices. Represented +30% of contract services revenue.
• Transferred projects into production: cardiac diagnostic (Genzyme), blood analyzer (Careside), laparoscopic applications, anthrax detection (Alexeter), microwave RF ablation (Microsulis), drug delivery (Baxter), radiation therapy (Cordis), cervical cancer detection, glucose meter (Abbott), and drugs of abuse detection device.
• Shared management in high volume (80k unit/mo) semi-automated glucose meter production line for Abbott.
• Drove six-sigma engineering changes and continuous improvement efforts to increase production line efficiencies, reduced quality problems, and increased profit margins by 30%. Executed DFSS project in R&D (June 05’).

Confidential

Evaluations Manager/Senior Quality and Reliability Test Engineer

Responsibilities:

• Responsible for all quality, testing and evaluation efforts on medical devices (i.e. blood analyzer, cardiac assessment device, syringe pump, radioactive ribbon deployment device for blockage of arteries).
• Responsible for design verification, reliability, environmental, packaging, safety, and packaging/transport testing.
• Managed and conducted software verification and validation testing.

Confidential - Columbus, IN

Senior Product Development Engineer

Responsibilities:

• Responsible for design, development, and test engineering support for five gear pump platforms, a 68 part fuel pump component line, a fuel pump housing line, and a large volume fuel pump assembly area.

Confidential

Founder/CEO/Senior Consultant

Responsibilities:

• Responsible for all engineering, quality and regulatory activities.
• Position the company for investment opportunities.

Confidential - NASHVILLE, TN

Director of Product Development & Partner

Responsibilities:

• Responsible for developing design inputs and outputs for early prototype builds
• Lead documentation creation for investment opportunities.

Confidential - Castlerock, CO

Product Development and Quality Consultant

Responsibilities:

• Aided in the development of the APPY System (IVD appendicitis POC device) with a R&D firm.
• Conduct technology and technical documentation audits in preparation of FDA 510k submission.
• Created and enhanced SOPs and work instructions to support ISO13485/21 and CFR part 820 quality systems.

Confidential - San Diego, CA

Medical Device Consultant

Responsibilities:

• Responsible for creating development plans and costs for 2nd gen hand-held LDX cholesterol screening device (CLIA). This device is currently used in Walgreens Minute Clinic.