Process Development Specialist
hace 2 semanas
About Us
Heraeus Holding Gmbh is a leading global family-owned company with a long tradition of innovation and excellence. Our commitment to innovation has enabled us to expand our business over time and today we operate in numerous countries around the world.
Job Description
As a Process Development Specialist, you will be responsible for developing and implementing new manufacturing processes for electrophysiology catheters and similar products. The ideal candidate will have a strong background in medical device development or manufacturing, with experience in process design, development, validation, and optimization.
Responsibilities:
- Develop and implement new manufacturing processes for electrophysiology catheters and similar products
- Collaborate with cross-functional teams to ensure successful introduction of new products into manufacturing
- Utilize process characterization skills and tools such as Design of Experiments (DOE), pFMEA, scale up factors, mitigation to foreseen risks, and capability analysis
- Ensure that proper technology processes are developed, implemented, maintained, and documented
- Work closely with development and production operators and technicians to resolve production issues
- Participate in process improvement initiatives to increase efficiency and quality
Requirements
- Bachelor's Degree in Engineering (Mechanical, Biomedical) or related technical field required
- A minimum of 4 years engineering experience within medical device development or manufacturing environment
- Familiarity with cGMP/GLP/GDP guidelines, ISO 13485, 21 CFR part 820, etc.
- Demonstrated strong technical writing skills to support and drive process and qualification documentation required
- Experience with guidewires or catheter manufacturing processes preferred (Wire grinding, profiler, inspection equipment, and CNC machining are desired)
- Demonstrated experience of process development, capability, optimization, and validation
- Application of statistical and analytical methods such as DOE highly desired
- Experience with troubleshooting, maintenance, and repair of manufacturing equipment
- CAD/CAM experience or training; SolidWorks highly desired or equivalent job experience
- Must possess proficient written and oral communication skills and ability to utilize MS Office suite tools
- Previous experience in document control and SAP preferred
- Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% - 15% travel)
- Proficiency in reading, writing, and speaking English
- Must be able to clearly articulate and listen attentively to questions, concerns and feedback from coworkers and customers
- Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations
- Highly motivated hands-on engineer with the ability to work independently and as part of a cross-functional team
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