Staff NPI Engineer (P-4551)

We are seeking a Staff NPI Engineer to join the Instrument Manufacturing Engineering Team. This role is instrumental in creation of the NPI team in Singapore including creating governance for supplier management, CM capability, and engineering project management. Additionally, this person will be responsible for the development and implementation of manufacturing process improvements, equipment/fixture/tooling design and qualification, process development and qualification, optimized to deliver high quality products and meet production demand. 

The ideal candidate will have a strong background in NPI, manufacturing and process engineering.  Knowledge and hands on experience with contract manufacturing, internal production assembly, calibration and control for instrument or capital equipment manufacturing.

What you will be doing:

• Teaming with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Define, measure and report key metrics for production quality and cost.  Collect data and analyze process performance and capabilities for internal manufacturing operations.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, implement mitigations, and leverage risked based decision making. 
• Create process requirements for both informing design activities, and to  implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design and process control, product configurations, manufacturing procedures, (e.g., travelers, bills-of-materials, Work Instructions, Lot History Records), and other Quality System requirements.
• Evaluate existing engineering processes and implement process improvements.
• Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap
• Using Lean principles, Lead and/or actively participate in product/process engineering problem solving.
• Identify opportunities and implement changes to improve products and reduce costs by using knowledge of assembly methods, quality control standards, fabrication processes, tooling, production equipment, product design, and materials
• Support the transfer of product lines and the qualification-validation efforts
• Prepare reports and presentations summarizing information or trends related to manufacturing performance
• Provide technical expertise or support related to manufacturing.

Minimum Requirements:

• Bachelor’s degree in Engineering: Mechanical, Electrical or Manufacturing with 7 years of experience, or MS/ PhD with 5 years of experience.
• Work history of qualifying multiple manufacturing processes. 
• Ability to review mechanical drawings, ability to read schematics
• Creation of pFMEAs, ECOs, work instructions, and qualification documentation.
• Experienced in Supplier Engagement and support, domestic and offshore
• Working knowledge of, but not limited to, manufacturing and assembly techniques, machining, injection molding, instrument and consumables for biotech
• Experience working with instrument manufacturing under ISO 13485 standards.
• Expertise in cGDP, cGMP.
• Ability to travel to contract manufacturers (approximately 10%)
• Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level.

Preferred Qualifications:

• Experience with SolidWorks, Oracle, Arena is a plus.
• Lean Six Sigma Green/Black Belt Certification

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