Manufacturing Engineer II
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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.
RESPONSIBILITIES:
- Execute projects with more complexity to support manufacturing production needs or new products transferred in the production area.
- Communicate and get support from different areas assuring that production running without interruptions and products and processes improvements are align with standards and quality system.
- Implement engineering tools (Six Sigma DMAIC, DOE's, Lean) to assure the problem solving, decision making and continuous improvement.
- Perform the documentation and records, after production release assuring the manufacturing and quality regulations
- Perform the validation process of the projects to accomplish whit the quality regulation for products and processes
- Assures that production lines output meets the specifications of the product to have clear criteria of conforming/ non-conforming product and the test methods used for verifying conformance.
- Provide information during audits to demonstrate the compliance of quality regulations.
- Promote continuous improvement in products and processes to reduce the risks of interruptions in production or quality regulations, it includes implementation of business initiatives.
QUALIFICATIONS:
- Engineering bachelor's degree or related
- Validation manufacturing process experience
- Excellent bilingual (English/Spanish) verbal and writing
- Normative ISO13485 Knowledge
EDUCATION:
- 3 to 5 years of experience in similar positions
- 3 to 5 years in medical cluster
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