PROFESSIONAL SUMMARY:

A seasoned engineering professional of 35 - years with 11 years’ experience in medical devices including R&D/product development, project management, quality and risk management. Background also includes management of supplier change and engineering change control, and management of product safety for infant care products. I am passionate about and strive for continuously improving quality of life.

KEY STRENGTHS & CORE COMPETENCIES:

21 CFR 820 / ISO 13485

Six Sigma Green Belt

Risk Mgmt / ISO 14971

Design Verification

Change Management

Project Management

Development Planning

Transfer to Manufacturing

Manufacturing support

PROFESSIONAL EXPERIENCE / EMPLOYMENT HISTORY:

Confidential, Lake Forest, IL

Development Engineer

Responsibilities:

• Performing sustaining engineering function for combination parenteral products, providing support for activities such as line extensions, writing protocols and reports and developing specifications.
• Adept at change control and supporting various team needs such as supplier support and label development.

Confidential, North Chicago, IL

Risk Management Engineer and Product Engineer Contract Engineer

Responsibilities:

• Supported maintenance of design inputs and design outputs, and maintenance of design history file.
• Developed protocol and performed testing showing fluid dynamics principles correlated with wide variation in syringe performance, indicating that measuring performance using current methods may be impractical.
• Supported launch of medication auto-injection pen including package testing, paper-based design verification and design validation activities, and coordinating activities with ex-US based production site.

Confidential, West Chester, PA

Risk Management Specialist Contract Engineer

Responsibilities:

• Managed remediation of medical device design and use Confidential ’s on various products including bone screws, external fixation, and small bone fragment fixation.
• Led risk management (RM plan, Confidential ’s, risk report) on a significant new product development project required identifying risks, failure modes and causes that had never been considered before.

Confidential, Lake Forest, IL

Risk Management Specialist and Systems Engineer

Responsibilities:

• Developed the foundations for new Confidential procedure and procedural infrastructure for the Risk Management group.
• Researched trends in product failures and complaints, investigated causes of component failures, performed trending and reported results.
• Performed lab testing on infusion pumps to quantify occlusion alarm performance.

Confidential, Chicago, IL

Senior Product Safety Manager

Responsibilities:

• Managed regulatory compliance, tested to federal/retailer/industry requirements and collaborated on safety issues with competitors to support the ASTM standards setting process for children’s products.
• Collaborated with Consumer Product Safety Commission (CPSC) and Health Canada on safety and compliance related issues.
• Drove compliance to industry’s safety program.
• Led industry effort to increase lab-to-lab test consistency when performing ASTM walker test by identifying differences between labs’ procedures and equipment. Costs from single false failure were approximately $40k.
• Wrote several company responses to CPSC proposals which became the bases for industry’s trade group responses. Presented arguments before CPSC during working-group and public meetings.

Confidential, Sidney, OH

Manager, Supplier Change and Refrigeration Engineering Change

Responsibilities:

• Managed 3 supplier change coordinators and 5 engineering change coordinators working with 18 global assembly plants to provide changed parts and parts from new suppliers to the plants for Operations-level feedback.
• Supervised supplier change process improvement team using Juran and lean office principles to create a streamlined process, minimizing missed hand-offs and allowing for cost savings to be captured earlier.

Senior Supplier Quality Engineer

Confidential

Responsibilities:

• Provided supplier quality support to new applications team and to business unit providing complete refrigeration systems, both requiring components in small-volumes.
• Saved $25k per month in x-ray inspection and returned systems costs by demonstrating intermittent failures of customer-designed refrigeration system were due to an element of their design.
• Completed Emerson’s year-long quality education program for future quality leaders.

Confidential, Vandalia, OH

Director of Product Safety

Responsibilities:

• Managed 3 direct reports to support development teams, safety-related complaints, and FDA requirements.
• Interacted positively on a regular basis with customers by phone, in-office and in-home.
• Planned and led several successful product recalls coordinating R&D, Legal, Customer Service, Sales and others.
• Implemented new hazard analysis process making safety and compliance reviews more open and interactive, identifying safety-related issues beyond standards earlier, minimizing safety-related development delays by 50%.
• Supported teams by researching new technologies, and investigated and responded to regulatory inquiries.
• Introduced Confidential to company, increasing understanding of product design and its relationship to product safety.

Confidential, Salt Lake City, UT

Senior Pilot Engineer / Senior Product Development Engineer

Responsibilities:

• Developed a robust design verification test plan for anti-friction coating which determined coating had inadequate adhesion, saving the costs and possible citation of introducing product which did not meet claims.
• Led successful matrixed team project for multiple-category line extensions incorporating new technology while minimizing additional costs by finding creative solutions such as use of some existing packaging.