Philips Ultrasound

Test Engineer on contract to Philips Ultrasound, Reedsville, PA

Jun 2013 - present: Test Engineer

Proprietary or confidential content is not present.

Philips Business Card

Summary: I was a contract engineer at Philips, hired for three consecutive projects summarized, (then later detailed) below. Philips Ultrasound was a great experience in both a large modern 'matrix managed' corporation, and in another FDA regulated environment. Experience in accomplishing cross-site team goals in fast-paced global projects was strengthened, and new techniques learned. Before I get into the 3 main formal projects for which I was contracted, let's cover some of the excellent cultural formalizations I found at Philips. Many of these were just that, formalizations. That is, various habits of organized, documented validated work were formalized, I thought so they could be more easily taught across the workforce. Whatever the reason, these best practices and more were practiced as a fully internalized part of Philips culture. I liked it.

My experience at Philips was in three formal phases, corresponding to contracted projects and listed chronologically:

Phase 1: Hecate Project: Team member on cost reduction project to generate engineering specifications to allow additional vendors to quote active ultrasound cables. 'Active' in this sense means the cables contain active electronics, such as references, sense amplifiers, and fault detection circuitry.

My responsibilities for the Hecate Project were concluded and documented ahead of schedule.

Phase 2: DfX project: My contract was renewed for another project called 'DfX', which means 'Design for Cost'. This project involved re-design of several high volume products in such a way as to reduce cost. This is an FDA regulated environment. My main responsibility to this project was to understand documented qualification requirements for proposed design changes, write qualification plans which could withstand FDA scrutiny at audit, then execute those plans in such a way as to obtain all necessary signatures for implementation of the design change. A plan was written which conformed to all applicable regulations and documentation.

In many industries, and Philips was no exception, qualification plans for design changes are based on an FMEA(Failure Mode Effects Analysis), or other method of assessing risk in a quantifiable manner, such that subsequent testing has a basis for mitigation. I assembled an FMEA (or Risk Assessment Team) of subject matter experts, and created Pareto charts necessary to justify linkages of the tests of the qualification plan to the weighted risks.

The qualification plan was structured in such a way that an Engineering Technician could carry it out, and in the meantime, a 'hot project' was developing with regard to a CAPA (Corrective Action Plan) regarding a key supplier, APEX. This was a serious compliance issue, and a 20 person team was assembled to solve the problem. I was assigned to lead a 5 person sub-team of the overall Apex project team.

Phase 3: Apex project: This project, like the Phase 2 'DfX' project was non-technical, rather the emphasis was on the interrelationship between the QMS systems of two companies, and structuring manufacturing control documents in such a way as to ensure FDA compliance. I believe Ed Bratton suggested my to lead the team I dubbed 'the BOM Squad', BOM being short for Bill Of Material. We lead organization of the group around a shared progress tracking spreadsheet through which project manager (Herb Cline) could quicky ascertain our progress. Although we were allotted 90 days to resolve BOM discrepancies around the Apex Acquisition we resolved the BOM's in 35 days, so were able to take on responsibilites of resolving discrepancies in test systems and test requirements specifications. I learned of some difficulties in merging disparate systems, which evolved to serve different cultures of manufacturing. It was also extremely gratifying to work with Joyce Chiang and others at the APEX Shanghai facility.

More detail on this 'Apex' phase will be forthcoming upon request.

My teams responsibilities to project management were completed slightly ahead of schedule.

Giving more meaning to the bullet lists: extended descriptions are 'strong', thus.