Manufacturing Engineer II-III Electrophysiology (56871)
UV Process Technology Solutions
About Heraeus
Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and cutting-edge technologies to create products used all over the world 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.
Essential Duties and Responsibilities
• Daily support to the EP manufacturing activities to meet established goals for safety, quality, cost and production.
• Estimate and understand product cost components and its interactions, (direct & indirect material costs, labor, overhead, variances).
• Use key performance indicators data such as yield, nonconforming material, or cycle time to take action and initiate projects/initiatives to maintain indicators under control.
• Develop and execute on continuous improvement initiatives to improve efficiency in the manufacturing lines.
• Use statistics to facilitate decision making and to draw conclusions from available data.
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends for Heraeus and its customers.
• When necessary, support customer meetings related to projects or production performance reviews.
• Perform installation/validation activities for new or existent production lines, meeting regulatory requirements. This includes equipment, process, product and test method validations.
• Ensures Manufacturing Procedures and Work Instructions are clear, effective and in compliance with regulatory and QMS requirements.
• Keeps equipment operational by coordinating calibration, maintenance, and repair services; follows manufacturer's instructions and established procedures; requests special services when needed.
• Participates in the identification and investigation of non-conforming products. Uses root cause problem-solving techniques to identify and eliminate causes, implements controls, and defines preventive activities.
• Ensures that production line output meets product specifications.
• Has clear criteria for conforming/non-conforming products and the test methods used for verifying conformance.
• Leads or supports CAPA investigation processes, or exception documents such as complaints investigations.
Minimum Qualifications
• Degree in one of the following fields: Electrical/Electronics Engineering; Mechatronics, Electromechanical or Mechanical Engineering; Materials or Physics Engineering.
• Advanced/Fluent English is a must requirement.
• 4+ years’ experience in Medical Device Manufacturing. Catheter experience preferred.
• Hands on Exposure to Technologies and equipment used in Medical Device Manufacturing.
• Proficient with MS Word, Excel and other Microsoft Office tools.
• Highly Analytical, organized and business/service oriented.
• Able to problem solve and think independently in a constantly changing medical device manufacturing environment.
• Statistical techniques knowledge (DOE, SPC, etc.) is required plus experience with continuous improvement methodologies, such as lean manufacturing, value stream mapping, or similar.
• Basic knowledge of FDA, GMP, and ISO guidelines is needed.
• Experience supporting production lines in the medical device industry and leading root cause investigations used problem solving methodologies.
• Experience using ERP systems desirable. SAP Experience preferred.
• Ability and willingness to travel internationally to support process, product, and equipment transfers is highly preferred (5% - 15% travel)
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