Senior Engineer - Process Development
Apply now »Date: Nov 18, 2024
Location: Fridley – Minnesota, US, 55421
Company: Heraeus
About Heraeus
Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a family-owned global technology group headquartered in Hanau, Germany, we combine materials expertise and technological leadership to create the most diverse products, all with one thing in common: World-class quality.
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.
This position is a technical leader and mentor within the process development team responsible for creating robust and sustainable manufacturing processes for complex electrophysiology catheters and sub-assemblies. As a Senior Engineer, you will provide the technical leadership for the commercial release of products to production by working cross-functionally through the electrophysiology product development process.
The following challenges await you:
- Provide technical leadership in the execution of the process design, development, and validation activities for medical devices through the product development process.
- Independently determine solutions for complex problems, process selection decisions, and technical challenges.
- Utilizes process characterization skills and tools such as Design on Experiments (DOE), pFMEA, DFM, and statistics to make data driven decisions.
- Mentors other engineers and promotes a culture of feedback.
- Ensure that proper technology processes are developed, implemented maintained, and documented to successfully introduce new products into manufacturing.
- Leads efforts to investigate, develop, and implement new technology.
- Works collaboratively with technicians and operators to solve technical problems.
- Establishes internal global or regional relationships and collaborates to ensure best practices utilized.
- Other duties may be assigned.
Your profile:
- Bachelor’s degree in an Engineering discipline or related technical field required
- A minimum of 8 years engineering experience required including previous experience in the medical device industry
- Expert level knowledge and application of processes development
- Demonstrated experience of process development, capability, optimization and validation
- Able to communicate complex technical concepts to broad audiences
- Proficient verbal and written communication skills in English
- Experience improving processes
- Experience creating documents such as process validation protocols or engineering studies that demonstrate technical rationale for associated decision
- Proficient at solving problems in a timely manner
- Must be willing and able to travel up to 25% or as needed, mainly between Minnesota, USA and Costa Rica
- Catheter manufacturing or process development experience
- Electrical Engineering, Flex Circuit, and ACF bonding process development knowledge preferred
Nearest Major Market: Minneapolis