- Support NPI team and participate in cross functional initiatives relating to NEW product design / development, validation activities, process qualification and transfer activities
- Support in drafting and execution of Transfers & Qualification Strategies, Master Validation Policies / Planning, Product / Process Validation Plan, Quality / Process Control Plan, Design / Process Failure Mode and Effect Analysis (FMEA) and Tools / Fixtures Installation Qualification (TFIQ)
- Lead in setup of Bill of Material (BOM) and routings, product drawings and revise assembly procedures as necessary in support of product design / production process transfers
- Lead in drafting and revising of product and process assembly procedures to enhance/clarify of contents
- Support packaging engineering validation efforts in support of product design / production process transfers and valve engineering projects
- Lead Manufacturing builds (feasibility, qualifications, commercialization) in cleanroom and be able to train and resolve manufacturing issues on the floor with sustaining engineers.