New Product Introduction (NPI) Engineer

DescriptionThe 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 ResponsibilitiesCustomer 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:Process validation (OQ/PQ where applicable)Equipment qualification (IQ/OQ/ where applicable)Test method validationInstallation and setup verification (FAT/SAT) Support activities related to:First Article Inspection (FAI)Process capability studiesRisk assessments (PFMEA)Product & Process Documentation Generate and maintain required documentation including:Test reportsProcess flow diagramsWork instructionsValidation reportsEnsure 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.RequirementsEducation, 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:PFMEAControl PlansDesign 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 simultaneouslyTypical 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.