New Product Introduction (NPI) Engineer

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Description

The New Product Introduction (NPI) Engineer is responsible for leading the implementation of new products from development into full-scale manufacturing. This role ensures that product manufacturing processes, equipment, designs, and documentation are fully validated and ready for operational handoff. The NPI Engineer collaborates cross-functionally with Engineering, Quality, Supply Chain, and Operations to establish robust, repeatable production processes and ensure a smooth transition into ongoing manufacturing. All design work must be executed in accordance with current Quality Management System (QMS) requirements.

Key Job Responsibilities:

Customer Product Implementation (aka Product Realization) / New Product Implementation

• Lead the introduction of new customer products into manufacturing.
• Review customer designs, specifications, and documentation to ensure manufacturability and compliance with internal capabilities.
• Lead the introduction of new products from development into manufacturing.
• Develop and execute operational implementation plans for product launch and manufacturing readiness of customer projects.
• Coordinate cross-functional activities required for product introduction, including engineering, quality, supply chain, and operations.

Process Development & Setup

• Define and document manufacturing processes, workflows, and work instructions.
• Support design for manufacturability (DFM) and design for assembly (DFA) reviews.
• Identify tooling, equipment, fixtures, and infrastructure required for production.
• Collaborate with engineering and operations teams to optimize assembly processes and material flow.

Validation & Qualification

• Develop and execute validation protocols such as:

o Process validation (OQ/PQ where applicable)

o Equipment qualification (IQ/OQ/ where applicable)

o Test method validation

o Installation and setup verification (FAT/SAT)

• Support activities related to:

o First Article Inspection (FAI)

o Process capability studies

o Risk assessments (PFMEA)

Product & Process Documentation

• Generate and maintain required documentation including:

o Test reports

o Process flow diagrams

o Work instructions

o Validation reports

o Ensure documentation is complete and ready for operational use.

Pilot Builds & Production Ramp

• Plan and execute pilot builds and initial production runs.
• Troubleshoot product and process issues during scale up and early manufacturing.
• Implement improvements to optimize quality, efficiency, and yield.

Transfer to Operations

• Ensure manufacturing processes are stable, documented, and ready for production teams.
• Conduct formal handoff of products and processes to Operations.
• Train operations personnel on new processes and product requirements.
• Provide training and technical support to production teams during ramp-up.
• Ensure successful transfer of validated processes to production teams.

Continuous Improvement

• Capture lessons learned during projects.
• Support ongoing improvements in manufacturing readiness and product launch processes.

Requirements

Education, Skills and Experience Requirements:

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.
• 3-7 years of experience in manufacturing engineering, NPI, or product/process development & implementation.
• Experience supporting product launches or manufacturing transfers in regulated manufacturing environments.
• Strong understanding of manufacturing validation and documentation practices.
• Strong problem-solving and root cause analysis skills.
• Experience working in cross-functional teams.

Preferred Qualifications

• Experience with manufacturing validation methods (e.g., IQ/OQ/PQ).
• Knowledge of GMP and clean room manufacturing environments.
• Familiarity with quality and manufacturing tools such as:

o PFMEA

o Control Plans

o Design of Experiment (DOE)

• Knowledge of Lean Manufacturing or Six Sigma principles.
• Statistical Analysis (ppk, cpk)

Key Competencies

• Cross-functional project coordination
• Strong technical documentation skills
• Process development and optimization
• Strong communication and organizational skills
• Process validation and qualification expertise
• Structured problem solving and root cause analysis
• Ability to manage multiple NPI projects simultaneously

Typical Work Environment

• Combination of engineering office and manufacturing floor environment.
• Frequent collaboration with quality, operations, and customer engineering teams.
• May require Occasional support during pilot builds, validations, and production ramp-up activities.