NPI Senior Engineer

Job Title:

NPI Senior Engineer:

Job Description: The Role: Senior Engineer, NPI Engineering

The Role of Fluid Management Senior NPI Engineer(L3) located in Munmak Korea will be established to drive new products into manufacturing through close collaboration with the product development and manufacturing engineering teams. This role will report to the global FM NPI leader and will provide support to the Munmak and Jangan sites.

In this role you will:

• Successfully transfer new products from the Research and Development(R&D) and/or New Product Development Engineering(NPD/PDE) teams into the manufacturing organization with a focus fluid handling, and packaging.

• More specific tasks will include:

• Control plan and FMEA creation and updates

• Design, creation, and execution of Validation and Qualification (V&Q) protocols for new products/process including statistical analysis. Help to establish standards for V&Q protocols within FM NPI.

• Develop Manufacturing Plans for assigned projects. This will include the selection of manufacturing site, raw and finished goods material planning, chemical/waste plan, ramp/capacity planning, cost roadmap, etc.

• Support new equipment and fixturing via design input, and commissioning ownership

• Optimization of processes during scale-up to improve cycle time and yield when required

• System setups to enable production of new products within those systems including Bills of Material, Routings, Costing. Systems will include SAP, SPC(Cam Line), and Testing (LIMS)

• Creation of manufacturing documentation including work instructions and process records

• Training of operations personnel on new processes, products, and equipment

• Training of less experienced NPI engineers and personnel on the items listed above

• Use of Accolade project management tool to track progress of all major projects and ensure all deliverables are completed and uploaded in each phase of the project

• Collaborating with development and manufacturing teams to define robust products and process designs to ensure no surprises once products have been transferred to manufacturing

• Working closely with the Production cell team to ensure Manufacturing Readiness of the new product portfolio. You will engage with the Manufacturing Engineers, Production Supervisors, and Operators to drive the successful transition of products from early development to product release. This will include providing input from the NPI perspective to help in prioritizing and right-sizing the project/product portfolio.

Support continuous improvement and task force efforts as needed to ensure success of the new product portfolio and achieve business goals. This may include participation in design for six-sigma (DFSS) efforts.

Traits we believe make a strong candidate:

• Technical Flexibility and ability to learn new concepts quickly

• Ability and willingness for hands-on work with equipment and products

• Strong sense of ownership and accountability for assigned tasks

• Excellent Collaboration skills and ability to work across functions

• Motivated and self-directed team player with good interpersonal skills. Must have ability to reach out, communicate and influence personnel at all levels within the organization.

• Excellent documentation, communication, and technical writing skills

• Experience in transfer of products from development to manufacturing

• Experience with high purity fluid handling and packaging products

• Bachelor Degree of equivalent in engineering or materials sciences.

• Strong English language skills

Your success will be measured by:

• Successful and On-Time transfer of products to manufacturing compared to Accolade Gate Dates and IRDs

• Revenue from newly transferred products

• No unplanned events/excursions for new products in Mfg after transfer