NPI Engineer II – New Product Introduction

About the role

The NPI Engineer II will support the design, development, documentation, and validation of new medical device products and product transfers. Working within a cross‑functional engineering team, you will gain hands‑on experience in key engineering processes, process validation, and manufacturing workflows while ensuring compliance with quality standards.

Key responsibilities

• Support, participate in, and lead project meetings for product transfers and development initiatives.
• Assist and/or lead customer communications for assigned projects.
• Develop and maintain project plans, track milestones, budgets, and quality requirements.
• Contribute to status reporting, issue resolution, and action‑item tracking.
• Collaborate with production teams to troubleshoot processes and apply technical support.
• Evaluate and recommend test methods for specific product design requirements.
• Execute feasibility builds, documentation, testing, process development, equipment evaluation, and operator training.
• Perform Process Failure Mode and Effects Analysis (PFMEA) and support process validation activities.

Required profile

• Experience with product transfers, including leading or supporting teams from a sending site to a receiving site.
• Strong collaboration skills across cross‑functional teams, customers, and suppliers.
• Hands‑on learning mindset with a focus on quality compliance.

Required skills

• Process Failure Mode and Effects Analysis (PFMEA)
• Process validation
• Design verification
• Test method evaluation
• Equipment evaluation
• Feasibility build execution
• Technical documentation