Jun 2013 - present: Test Engineer
Proprietary or confidential content is not present.
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.
- Six Sigma. Intuitive? Perhaps yes after delving into it. I did not get to formalize a green or black belt certification, but kept statistical validity.
- This Lean site covers a number of what I would call 'common sense organizational methods', that now have formal names, so, we can communicate about them and make them work better for us. A few are listed below. And at the risk of seeming like a non-believer (which I am not), a key high ranking supply chain individual at Philips once confessed: "Lean is fantastic, but just a little inventory cures many oversights". This persons identity will remain a secret. ;-)
- 5S training. Really a no-brainer for me, and Dave Lauder will tell you I should tone down the OCN (Obsessive Cubicle Neatness). I applied 5S to my personal computer organization as well, so when a project was over, everyting was neatly bundled, sippable, and indexed by Word docs with links to dig down into project archives and keep things in context. AND, applying 5S to your hard drive lets you find and retrieve materials faster. This is super handy in online meetings.
- Kaizen. Again, thanks Dave.
- And lots of other formalized tools to let the wheels turn smoothly in a complex organization with complex products.
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.
- (Hecate project) Lead supply chain effort to harmonize vendor test programs for active ultrasound cables This included the creation of performance requirements documents, and design qualification This project involved creating performance (electrical, mechanical, reliability, and safety) requirements for second-sourcing ultrasound cables. (A list of specific tests is available upon request.) This activity was conducted in concert with resolving disparity between testing capability of the alternate vendors. Predecessor documents were generated over a 10 year period and across multiple global sites and engineers. The specifications required consistency and careful review for validity of requirements.
- (Hecate project) Lead technical team to solve problems transferring designs to alternate vendors This included cross site technical coordination and actual bench time troubleshooting parasitic feedback to sense amplifiers This unusual situation was unanticipated by program management, and was solved using instrumentation and troubleshooting skills. Continual problems occurred with alternate vendors ability to provide samples of certain cables which would pass fundamental image quality tests. The root cause of image artefacts had eluded Philips. This was not due to any technical deficiency, merely that no-one was tasked with getting to the root cause. However, for our project to succeed, it was vital that root cause be determined and that corrective action be proposed.
To managements pleasure, I took the initiative to apply differential techniques and strategic triggering to samples of the devices using a LeCroy Waverunner oscilloscope. This initiative, backed by technical experience, lead to indisputable proof of the root cause failure mechanism.
- (Hecate project) Developed ROI (Return on Investment) analysis for next generation test stands based on existing testing, and extrapolations of current problems which were appropriate to solve by sampling more sophisticated tests. The plan was adopted. Test system development lagged slightly behind developments in product design sophistication, specifically, the rise of active elements within the cable assembly created IQ/OQ (Incoming Quality / Outgoing Quality) discrepancies between the contractor and vendors. That is, there were critical aspects of cable design, (parasitic characterization) which were unanticipated. The organization was unable to move forward in with a sound technical solution without having a solid cost justification. The technical solution had been held up for about one year due to lack of an ROI. My initiative in assembling this justification allowed the technical solutions to proceed.
- (Hecate project) Discovered 6 sigma opportunity, performed statistical study on existing measurement systems to document underutilization of resolution, documented lean alternative plan using existing measurement systems to avoid investing in high overhead replacement systems This opportunity exists because a proprietary impedance measurement system called a 'MIMS box' was typically used at a particular frequency in the cable specification. This test frequency was derived from the overall product specification of the finished product, and was not selected to be optimized at the sub-assembly (cable) level. I collected an adequate sample of representative data across a range of frequencies to show that the MIMS device was capable of achieving resolution to allow upper and lower control limits to be established which allowed cable manufacturing variance to be observed.
This resultant ability to discriminate good from bad sub-assemblies will have a direct impact on supplier relationships which are impacted by unreproducible rejections at incoming QC.
- (DfX project) Assimilated governing internal requirements to qualify design changes in an FDA regulated environment. Wrote design change qualification plan which assured regulatory findings would be avoided in future audits. This involved using the proprietary EDM (Electronics Documents Management) system (eMatrix)to locate applicable internal requirements for qualifying product design changes and releasing changes to production. The stated task was to write a qualification plan for the proposed design changes. It was apparent any qualification plan should be able to withstand regulatory scrutiny, so it was necessary to assimilate the appropriate requirements in short order so a quality plan would result.
- (DfX project) Analysed signal path variance in ultrasound transducers to implement cost-saving redesign (DfX project) Among the most sensitive types of modification to ultrasound transducers is any modification which changes the electro-acoustic signal path. A cost-saving re-design was proposed by a Senior Scientist which removed several expensive and redundant multiplexers from certain channels of the acoustic path.
Before the expense of PCB layout and other re-design costs were incurred, I personally de-soldered multiplexers from working production samples, and inserted a first-order (resistive) substitute for the parasitic impedance of a multiplexer. These samples were then subjected to acoustic and other tests. Acoustic tests involved characterizing proprietary aspects of return echo pulse waveforms.
Test results were tabulated in both MiniTab, and by using an internal proprietary statistical analysis method in a new way. Specifically, statistical analysis was traditionally done on unit-to-unit variability, without regard to intra-unit variability, that is, I applied statistical methods to individual elements across the face of the ultrasound transducer.
What was learned: the intra-element variances of the reference population (normal production units) to the variant population (the prototypes I modified) was noticeable, and within reason to proceed to invest in the cost-saving course of action which was proposed.
As important as the economy of forward visibility the test provided, was the relationship to the FMEA(Failure Mode Effects Analysis) which necessarily drove the qualification plan.
- (DfX project) Built a novel heating unit which allowed collection of intra-element performance data over temperature. This activity was required to provide realistic risk analysis under operating conditions which are stated in literature and internal product specifications.
- (Apex project) Lead reconciliation of product documentation to improve FDA compliance wrt. Apex, a key transducer supplier to Ultrasound (Apex as a Supplier project). This included resolving BOM's between Asian and Domestic manufacturing sites, and harmonizing test specifications.
This project involved over 50 different finished goods and sub-assemblies. For this project to be successful, i.e to achieve it's compliance goals, work had to be coordinated across sites and on a cascaded schedule.
While Microsoft Project may have been a good tool for management purposes, I elected to set up a shared spreadsheet and quickly establish training for the team. The spreadsheet served two purposes: management viability of project progress, and to provide an audit-able record of the procedures which were used to achieve project goals. This record was essential due to the regulatory (FDA) aspects driving the project.
- (Apex project) Facilitated cross-site strategy development and implementation for Apex as a Supplier project.
The project was 'out of the ordinary', in that it addressed a compliance situation which should not have come to exist. It was therefore necessary to bring a variety of high level departments and individuals (Senior management and VP level) together in a solution which met all objectives. The most challenging was of course the Quality and Regulatory (Q&R) department.
A two-stage plan was developed which reconciled BOM (Bills of Material) disparity between sites, then resolved harmonization of test specifications. All parties agreed with and signed off on the plan.