Experienced NPI Engineer

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Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

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

* Bachelor's degree in Mechanical, Industrial, Electrical, Biomedical, or related engineering field.

* 3-5 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

Required Skills:

Preferred

Skills:

Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing