Lead Hardware Engineer

Engineering Change Requests Specialist

Specify changes that need to be made to parts. Work with the Product Lifecycle Management (PLM) Tool used by the client (GE Healthcare) to make changes to products including Bills of Materials (BOMs), Model Configuration Records (MCRs), etc.

Present ECRs to Engineering Change Control Board (ECCB), explain justification for making changes to members of the ECCB, which includes subject matter experts and stakeholders. Consider their feedback and revise ECRs as necessary.

Tools: My Workshop - MWS (PLM), NitroPDF, Excel

Professional Duties

Work on Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).

Specify changes that need to be made to parts. Work with the Product Lifecycle Management (PLM) Tool used by the client (GE Healthcare) to make changes to products including Bills of Materials (BOMs), Model Configuration Records (MCRs), etc.

Present ECRs to Engineering Change Control Board (ECCB), explain justification for making changes to members of the ECCB, which includes subject matter experts and stakeholders. Consider their feedback and revise ECRs as necessary.

Tools: My Workshop - MWS (PLM), NitroPDF, Excel

Work on releasing parts for production, ensure all necessary specifications are attached to the part in the PLM tool, ensure all stakeholders approve release of part.

Tool: My Workshop – MWS (PLM)

Document Creation

Create and update existing documents to meet medical device regulations:

• Product Packaging Reports: List new shippable items being released, and provide justification to show they won't be damaged when shipped. This can include test results, or noting similarity with existing parts that have been deemed safe to ship.
• Bay/System Configuration Reports: Record configuration of test systems/bays and note the established condition (fit for verification/validation/human scanning, etc.)
• Traceability List: Make list of new parts being released that will be traced, include information about design/task owners
• WEEE Passports: List new parts being released that could end up as electrical/electronic waste. List harmful substances contained in each of these parts.
• RoHS Compliance Reports: For each new highest-level part being released and added to systems, show that each child part contained in it is RoHS compliant

Tool: My Workshop – MWS (PLM)