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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.