Senior Product Engineer – Senior Mechanical Engineering

Location: Newark, DE

Summary:

This is a key role within manufacturing responsible for developing and implementing supply chains and manufacturing processes for new subsystems used in medical devices.

The Senior Product Engineer will work with R&D, Procurement, Suppliers, Production, and Quality to come up with novel and inventive solutions for the cost effective manufacturing of subsystems and assemblies.

Responsibilities:

• Work with R&D to develop quality, manufacturable, testable, and lowest cost assemblies
• Work with Procurement to establish supply chain strategies for assigned subsystems including visiting and auditing supplier capability.
• Work with Suppliers to address technical issues with designs, production planning for prototype builds
• Work with Production to develop assembly and test process for assigned subsystems and support validation of the processes in preparation for launch.
• Work with Quality to perform root cause and corrective action of nonconforming parts and assemblies during prototype builds.

Qualifications:

• Bachelor of Science in Mechanical Engineering.
• 5-8 years of industry experience in product development and manufacturing with technical background in various manufacturing processes.
• Experience working with suppliers of complex assemblies to troubleshoot and resolve technical issues.
• 1-2 years Project Management experience.
• 3-5 years working in an FDA-regulated environment.
• Travel: 20-30% domestic and international.