Senior R&D Engineer Medical Devices (m/f/d)

Senior R&D Engineer Medical Devices (m/f/d)

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.

The following challenges await you:

• In your role, you are executing product development projects with a customer-specific design from concept freeze throughout the product design and manufacturing transfer and are able to mentor younger professionals on these tasks.
• You work in cross-functional teams with program managers, design and process engineers, prototyping assistants and RA/QA representatives within the global footprint of our company, as well as with our business partners and customers.
• You take over responsibility for the technical design.
• You develop and build prototypes - draft and hands on - for medical devices, designed for safe and effective use to improve the well-being of patients worldwide.
• You work in many areas of interventional devices, including access devices, advanced diagnostic and therapeutic catheters and complex delivery systems, applying the state-of-the-art technology.
• You develop test methods for design verification and simulated use validation, manufacturing processes for your solution, and document your work within our paperless PLM system.
• You ensure complete documentation according to regulations, standards and industry best practices under design control.
• You guide and mentor less experienced team members and keep stakeholders, customers, and others informed of the project status and upcoming issues.

Your profile:

• You have a bachelor's degree in a scientific or engineering discipline with a focus in Mechanical, Plastics or Biomedical Engineering. An advanced degree is preferred.
• You are working 5+ years in the medical device industry.
• You demonstrate a strong knowledge of interventional devices, applied materials, functional product design, design for manufacturing and prototyping skills.
• You have experience in mentoring and records to prove development experience for Class II and Class III medical devices.
• You can demonstrate the ability to make data-driven decisions utilizing statistical tools such as DOE, tolerance stack-up analysis, or Minitab.  
• You have very good communication skills in English (written and spoken).
• Of course you understand Design Control Requirements and ISO 13485 / FDA requirements.
• You are able to travel occasionally to customers, study locations or other company sites throughout the world?