Role : Lead Engineer
Location : Sandiego, CA
JD:
• Audits – independent set of eyes to review various records and compare according to procedural requirements for both infusion and dispensing (e.g. TMVs)
• Access to SAP and fluent in looking up materials, BOMs, etc.
• End to End knowledge of Product Lifecycle for an EMI product from Design Controls through Design Transfer, inclusive of Sustaining Activities in Production. For example, I have a project which will be to observe current production processes and create production specs (remediation) and then a traceability matrix that ties design outputs to final testing in manufacturing. Material Masters, Inspection Plans, Final MBIs and TIs may need to be updated.
• Another project, similar to above, trace EDOs and remediate downstream production activities to those EDOs (e.g. update inspection plans, compare testing and user manual, evaluate final acceptance and controls)
• Knowledge of environmental monitoring in warehouse
• Familiarity with RoHS requirements and creation of Environmental Files which will include working with suppliers and procurement
• Ability to travel back and forth to Mexico or live in Tijuana
• Exceptional English technical writing skills
• Ability to multitask and take on other assignments by me, Require frequent travel to Client plant, Tijuana, Mexico.
Nice to have:
• Prior knowledge of the MMS organization (knowing who to reach out to with a question)
• Knowledge of ESD directives, regulations and best practices
• Fluent in Q4, Q5, Q6, Q99’s in SAP and the processes associated with them – close QNs
• Can own CAPAs and perform investigations and corrective actions, has previously owned CAPAs and can assist CAPA owners
• Knowledge of Global Hold process at MMS
• Power Bi and ability to create dynamic reports or report on metrics