Heraeus Medevio · 6 days ago
Senior Process Development Engineer
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Medical Equipment Manufacturing
Insider Connection @Heraeus Medevio
Responsibilities
Provide technical leadership for an engineering team to design, development, validation activities through product life cycle for complex assemblies in accordance to project scope and budget
Lead complex process development and validation
Actively coach and mentor less experienced engineers
Provide significant guidance regarding technical strategies and approaches; works cross-functionally in identifying, analyzing and resolving technical issues.
Utilizes 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 to successfully introduce new products into manufacturing
Assume responsibility for robustness and accuracy of developed processes including establishing processes with high capability within project budget.
Able to communicate complex technical concepts to broad audiences
Consistently demonstrate creativity in applying engineering principles to solve complex problems
Able to make data-driven decisions utilizing engineering principles
Identify opportunities to work more efficiently and identify opportunities for improvement
Potential to manage people and support individual team member career development
Complies with policies, guidelines and regulatory requirements per Heraeus Medical Components Quality System
Other duties may be assigned as required
Qualification
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Required
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 (Principal Engineer requires a minimum of 12 years of experience)
Expert level knowledge and application of processes development
Demonstrated experience of process development, capability, optimization and validation.
Proficient verbal and written communication skills in English
Experience improving processes
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
Preferred
Catheter manufacturing or process development experience preferred
Laser process development knowledge preferred
Electrical or mechanical engineering, or electrical catheter system expertise preferred
Proficient verbal communication skills in Spanish preferred
Company
Heraeus Medevio
At Heraeus Medevio, we improve lives by bringing lifesaving and life-changing medical devices to market with our partners.