NPI Engineer

NPI Engineer

Permanent 

 

 

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

 

Job Purpose

Lead and execute the transfer established of new products, processes, and legacy products in alignment with company strategy and in compliance with applicable regulations and Quality Systems, in constant interaction with the customer for negotiation and strategic decisions to closure the product transfer process, complying on time according to expectations and budget.

Major responsibilities 

• Lead implementation activities related to guarantee the process transfer.
• Define the distribution of the different stages of the process transfers with the project manager to know the key information, lead time, resources, and customer definitions to accomplish the transfer.
• Create and/or update technical documentation of the transfer process assuring the information to allow decision making.
• Monitoring the ramp up process of the transfer production lines, controlling scrap and product variances using Lean Tools and methodologies (DMAIC or PDCA, Ishikawa, Pareto, Poka-Yoke etc.)
• Ensure the correct Cost of Goods Sold for each product in the SAP System for the new part numbers created as part of the transfer process to provide quality information regarding the profit of the product.

Requirements

• Bachelor’s degree or Master Degree (MS) desirable with a major in Engineering fields (Electronic, Materials, Maintenance, Mechanical, Electric, Industrial, Production).
• 8+ years in similar positions.
• 5+ years of work experience in medical industry.
• Advanced English communication skills.
• Experience in: Transfer Process Projects implementation and Continuous Improvement Projects implementation.
• Proficient in using SAP.
• Knowledge in normative ISO13485, CAPA, CAPEX, budget control and COGS.

 Preferred

 • Experience working with catheters.

 • Proficient using Minitab, AutoCad & Solidworks.

 • Knowledge in Lean and six sigma.

 • Valid Passport and Visa.