Manufacturing Engineer II
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About Heraeus
Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.
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.
Job Purpose
Execute manufacturing engineering actions, projects and investigations assuring the sustaining of production lines according to quality compliance regulations.
Major Responsibilities
- Coordinate the engineering process to allow the execution of priorities and projects according to manufacturing production needs.
- Coordinate with different areas (logistics, purchasing, planning and quality) assuring that production running without interruptions and products and processes improvements are in compliance with standards and quality system.
- Implement continuous improvement projects in products and processes to reduce the risks of interruptions in production or quality regulations.
- Keep and foster organizational environment to promote HMCR values and culture.
- Developed processes, documentation and records, after production release assuring the manufacturing and quality regulations.
- Execute manufacturing priorities and process according to the indicators of yield, quality, and cost, through methodologies (Six Sigma DMAIC, DOE’s, Lean) assuring the SPCs.
- Perform manufacturing technical support during the validation, and post-production to avoid line interruptions and high scrap
Education
- Electrical/Electronics Engineering; Mechatronics or related
Knowledge and skills
- Validation medical manufacturing process experience
- Statistical techniques knowledge (DOE, SPC, etc.) is required plus experience with continuous improvement methodologies,
- SAP basic knowledge
- Fluent in spoken and written business English
- Normative ISO13485 and FDA
- Lean and six sigma knowledge
- Knowledge in CAPEX, Budget control and COGS
- Software: Minitab
- Software: AutoCad & Solidworks
- Highly Analytical, organized and business/service oriented.
Experience
- 2+ years in similar positions in medical industry.
- Transfer Process Projects implementation.
- Experience supporting production lines and leading root cause investigations used problem solving methodologies.
Preferred requirements
- Catheter experience preferred.
- Continuous improvement projects implementation
ReqID: 58002
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