Senior Advanced Manufacturing Engineer
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Design Transfer:
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As a member of the project team, you will work closely with R&D, Manufacturing Engineering and Quality to transfer products into manufacturing.
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You will develop and implement manufacturing plans to accomplish a robust design transfer from initial concept to full production to support new products, product changes and enhancements.
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You will design and develop manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
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You will be responsible for creating and executing all validation plans, protocols, and reports (PC/IQ/OQ/PQ).
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You will be responsible for the product Cost of Goods Sold (COGS) and drive the project team toward cost effective solutions during concept and design selection.
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As part of the project team, you will be responsible for leading the pFMEA process, DFM/DFA, risk analysis and process control strategies.
Process Support and Improvement:-
Achieve Operations deliverables by working with Manufacturing Engineering and Quality to investigate production issues, identify failure modes to improve production throughput and yields.
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You must possess a broad understanding of current process technologies, bio/med device assembly methodologies, commercial fabrication techniques, creating and maintaining specialized environments, etc.
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You will research new manufacturing technologies and operational methodologies to ensure our products remain innovative and cutting edge.
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Provide training materials and training for manufacturing personnel for newly developed processes as needed.
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You will quantify current and future manufacturing requirements, perform capacity analyses, and implement capacity scale-up as required.
Supplier Management:-
Interface with outside vendors to address capacity or quality issues with components, materials, and subassemblies.
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Build and maintain strong relationships with manufacturing process and equipment suppliers. Identify alternative suppliers as needed.
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Work with Procurement Leaders at BrioHealth Solutions to identify alternative suppliers as needed.
Cross-functional Collaboration:
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Apply persistence and determination in organizing, managing, and motivating, cross-functional teams to implement and integrate new process technologies to meet market and revenue requirements.
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Work closely with various departments, including R&D, quality and manufacturing, to understand their needs.
Other:-
Accept additional responsibilities as assigned by manager or Operations management.
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Mentor and develop junior level Advanced Manufacturing Engineers toward professional growth.
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Identify technical risks, resource problems and work arounds.
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Development of intellectual property is required.
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Proficient in Microsoft Office 365 applications and tools.
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Strong organizational skills and attention to detail.
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Leadership skills and the ability to mentor and guide junior team members.
BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD®) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.