Experienced NPI Engineer

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Experienced NPI Engineer (Supplier & Process Engineering)

Job Summary

The Experienced NPI Engineer drives manufacturing and supplier readiness for new product introductions. This role leads the development and optimization of processes manages supplier qualification activities and ensures robust design transfer into manufacturing. The ideal candidate is a technically strong hands-on engineer with solid experience in NPI Supplier Engineering and Operations capable of independently solving complex problems and influencing cross-functional teams.

Key Responsibilities

• Lead the development and optimization of manufacturing processes for internal and external components and assemblies.

• Own and develop PFMEA process flows validation strategies and control plans.

• Conduct supplier capability assessments readiness reviews and drive corrective action plans where needed.

• Provide expert DFM/DFA/DFX guidance during design phases and influence engineering decisions through data-driven recommendations.

• Plan execute and document process validations (IQ/OQ/PQ) ensuring compliance and robust process performance.

• Manage PPAP deliverables and oversee supplier qualification to ensure production readiness.

• Collaborate with R&D Supplier Engineering Operations and Quality to ensure a seamless and compliant design transfer.

• Lead investigations of supplier or process issues using advanced problem-solving methodologies (8D DMAIC DOE).

• Ensure all documentation complies with quality system requirements and supports audit readiness.

Qualifications Required

• Bachelors degree in Mechanical Industrial Electrical Biomedical or related engineering field.

• 35 years of experience in manufacturing NPI supplier engineering or process engineering.

• Strong understanding of manufacturing processes quality systems and design transfer principles.

• Demonstrated ability to lead cross-functional activities and manage complex technical tasks.

• Strong analytical problem-solving and data-driven decision-making skills.

• Excellent communication stakeholder management and collaboration capabilities.

Qualifications Preferred

• Experience in regulated industries (medical devices highly preferred).

• Strong knowledge of DFX methodologies PFMEA development Six Sigma and validation standards.

• Proficiency with CAD tools statistical analysis software (e.g. Minitab) and DOE methods.

• Experience working with suppliers globally and managing external manufacturing readiness.

• Lean manufacturing or Six Sigma certification (Green Belt or higher).

Key Competencies

• Technical leadership & ownership

• Advanced problem solving

• Cross-functional collaboration & influence

• Attention to detail & structured documentation

• Quality compliance and safety-first mindset

• Continuous improvement orientation

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