Sample Projects PLS has Completed

• Staffed and led a team to bring the quality of a client company's acquisition into compliance – included design validation, process validation, and retrospective generation of design history files.
• In medical device research organization – with no hardware development experience – formed and led a team to develop a stimulation system for a novel therapy.
• Led PLS and client resources to rapidly launch an acquisition's product and integrate the new unit into the parent company.

• Led worldwide team to fix and return a medical product to the market after voluntary removal for quality issues.
• Discovered a material the customer had designed into a product that would never receive FDA clearance: Led team to clinical release with viable replacement material.
• Led worldwide notification of patients, physicians, and agencies about dangerous interaction between two unrelated medical devices.
• Rescued a failing Data Center electric-cooling-upgrade project for a billion dollar company and successfully completed project to meet critical business cycle needs.
• Discovered the telemetry frequency customer had designed into a product was an illegal FCC radio frequency. Identified recovery strategy and led team to successful commercial implementation.

• Acting in role as interim General Manager, turned around a failing division that was slated for closure.
• Acting as Manufacturing VP led the production ramp-up for a high-reliability medical product – from site remodeling through fully-staffed and operational facility.
• Led corporate process to assess entry into a new market, identified potential acquisitions, conduced due diligence and recommended action.

• Mentored a highly accomplished design engineer who was making the transition to project manager. After 10 months, not only was there significant improvement for the mentee but the overall organization.
• Mentored and supported a full time project leader to ensure a smooth market launch. Included managing design improvements, design history files, and preparations for regulatory submissions.

• Using a Six Sigma process, led a team through a lab reorganization netting a 20% increase in output using the same people, space and equipment.
• Led a hospital through a process to restructure elective admissions reducing outstanding invoices by >15 days and identifying a large uncollected debt write off.
• Leading a team from a major health care provider through a Six Sigma improvement process; netted 400K in annual savings (versus a $100K target).
• Replaced a stifling product development process with an effective, scalable process that netted faster release of higher quality products.
• Resolved / Closed >500 customer complaints in preparation for agency audit: Implemented a system for on-going, timely closure.