Job Description

NPI Engineer II – Job ID 11551

Internal Candidate Description (Brief):
Coordinate, lead, optimize, validate, and implement the introduction of new products and new manufacturing processes at the plant in collaboration with corporate and divisional counterparts. Ensure all activities comply with FDA and ISO quality requirements and guidelines. Deliver projects on time, within budget, and within defined scope by applying project management best practices.

• Develop manufacturing processes that are reproducible, scalable to required capacity, and safe, enabling sustainable growth according to business needs.
• Validate significant changes in production processes, ensuring proper execution in accordance with the current Quality System.

Education:
Bachelor’s degree in Mechanical, Electromechanical, Industrial, Materials, Chemical, or Electronic Engineering, or a related field.

Experience:

• Minimum of 2 years of professional experience in a technical field and in similar roles.
• Equivalent: 3 years of proven experience in the field and/or related areas.

Advanced Experience:
Demonstrated experience in a complex business environment. This is a fully qualified, advanced-level position requiring independent execution of responsibilities.

Specialized Knowledge (Desirable):

• Project management or business administration
• Lean Manufacturing, Six Sigma Green Belt
• Design for Manufacturability (DFM)

Languages (Desirable):

• English

Computer Tools (Desirable):

• Advanced Microsoft Office

Other Tools:

• AutoCAD
• SolidWorks
• Minitab
• Microsoft Project
• Visio
• Quality Companion

of Duties and Responsibilities:
Coordinate, lead, optimize, validate, and implement the introduction of new products and manufacturing processes at the plant in collaboration with corporate and divisional teams. Ensure compliance with FDA and ISO quality standards while delivering projects on time, within budget, and within scope using project management best practices.

Key responsibilities include:

• Develop manufacturing processes that are reproducible, scalable, and safe to support sustainable business growth.
• Validate significant production process changes in accordance with the current Quality System.
• Participate in structured problem-solving activities by organizing and planning efforts and applying technical expertise to develop effective and innovative solutions.
• Design, implement, and validate fixtures, tools, or specialized equipment required for production process changes, new product development, or product launches.
• Participate in project meetings with internal and external stakeholders to identify process challenges and provide timely and effective solutions.
• Coordinate with Manufacturing Engineering and the respective CSPO to implement projects that improve productivity and reduce scrap and rework.
• Analyze, develop, and execute actions related to CAPAs issued by the Quality department that involve NPI processes.
• Conduct engineering studies on materials and processes, investigate causes of nonconformities, and implement appropriate corrective actions.
• Prepare and perform functional testing of raw materials as required by First Article Inspection procedures to ensure compliance with the quality system.
• Apply project management tools and best practices to ensure successful project completion.
• Train personnel on acceptance and rejection criteria for raw materials, subassemblies, and finished products to maintain consistent quality performance.
• Review and update existing quality documentation and develop new procedures to integrate new processes into the company’s Quality System.

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