New Product Introduction (NPI) Engineer

Job Description

Job Description

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:

oProcess validation (OQ/PQ where applicable)

oEquipment qualification (IQ/OQ/ where applicable)

oTest method validation

oInstallation and setup verification (FAT/SAT)

•Support activities related to:

oFirst Article Inspection (FAI)

oProcess capability studies

oRisk assessments (PFMEA)

Product & Process Documentation

•Generate and maintain required documentation including:

oTest reports

oProcess flow diagrams

oWork instructions

oValidation reports

oEnsure 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.

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:

oPFMEA

oControl Plans

oDesign 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.