NPI Engineer

About the role

The NPI (New Product Introduction) Engineer is responsible for the development, qualification, and launch of new processes for manufacturing. Additionally, the NPI Engineer is responsible for improving NPI processes, training of new operators for OQ/PQ validation, and developing cost saving projects by deploying processing improvements.

Responsibilities

• Lead process development activities for New Product Introduction projects including prototyping, validation using IQ/OQ/OQ, and launch efforts during the entire product development process.
• Participate in related molding, inspection, characterization, and other manufacturing processes and assists in generating process documentation including process sheets, work instructions, SOP’s, control plans, and PFMEA’s.
• Perform process determination and DOE runs for process definition.
• Oversee First Article sample and validation runs.
• Develop new processes, tooling and manufacturing concepts that will meet customer expectations on cost, quality, and delivery.
• Create and execute validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling, and processes.
• Communicate status with the Project engineer, quality, and production team members.
• Identify areas for improvement in equipment and processes, and works with the engineering team to implement solutions.
• Train manufacturing operators related to material, molding tools, and equipment for NPI.
• Cohoperation and professional conduct with coworkers, staff, and managers.
• Meet Ingersoll Rand’s standards for quality and productivity.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Follow all quality procedures for traceability, line clearance, process control, safety, and housekeeping.
• Communicate effectively with Flexan’s employees and management.
• Demonstrate all the Ingersoll Rand corporate values.
• Provides engineering support for all activities in the product development process.
• Maintains the status of all new products and ensures effective execution of projects according to required policies, procedures, and government regulations.
• Works with design engineering and assists in the transition of design prototypes into cost-efficient and high-volume products.
• Develops prototype design according to required techniques and manufacturing processes.
• Designs new manufacturing process requirements and associate guidelines.
• Develops and implements efficient material handling, and flow strategies, and always maintains safety.
• Works with Quality Control team to generate, update and implement all project related documentation including control plans, work instructions, manufacturing procedures, sample request, process guides and troubleshooting guides.

Requirements

• Bachelor of science from a four-year college or university in an engineering or science related field.
• Must be motivated and creative, work well under pressure and operate effectively in a fast paced team environment.
• Must meet internal deadlines and customer due dates.
• Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
• Must be detail oriented, focused and able to produce accurate and professional documents.
• Advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).
• Solidworks or CAD modeling software is a plus.

Preferred Qualifications

• 3+ years’ experience in manufacturing engineering or a related field.
• Experience working with medical devices and associated regulatory requirements.
• Experience with product qualification and process validation activities.

Pay

The pay range for this role is $80-110k. The pay range considers a wide range of factors that include a candidate’s skills; experience and training; licensure and certifications; and geographic location.