This position will be responsible for supporting the development of new products and processes, ensuring optimal document and data processing, training planning and execution, and monitoring of process and product requirements.
Role and responsibilities
- Build product through pre-production phases in both a cleanroom and general manufacturing environment
- Support market research to understand the requirements for the development of new processes and products.
- Ensure proper processing of documents and data to ensure compliance with process/product specifications.
- Support the planning of process/product introductions
- Identify department needs to create appropriate process management and compliance
- Support the team in delivering product specifications and procedures to the manufacturing team for production purposes.
- Support the development of quality control criteria and safety guidelines and ensure that all team members adhere to them.
- Performs other tasks related to continuous improvement and process monitoring.
- Assist with execution of process and Test Method Validations
- Assist in the selection, design, and procurement of manufacturing and test equipment
- Installing and maintaining equipment / fixturing
- Understands cause and effect as it pertains to process development
Requirements
- Technical degree or advanced university studies in industrial engineering, administration or other engineering specialties
- 4 years´ experience in manufacturing and product transfer, preferably in the medical or highly regulated industries.
- Technical experience in braiding, reflow, grinding, adhesive bonding and soldering processes is desirable
- Competent to communicate in the English language, it is desirable that you have an intermediate level (B1 Belt reference)
- Good working knowledge of manufacturing and process validation and transfers
- Proven competencies in problem solving and demonstrated ability to collaborate with multiple stakeholders.
Requirements
Highly competitive environment
Benefits
Highly competitive package
Other open roles at Nextern(6)
Nextern is a collaborative medical device design company that designs, develops, and manufactures best-in-class medical devices with locations in Minnesota, Costa Rica, and Asia.
Key team members
Wesley Omer
John Hastings
Kevin Kopp
Tammy (Dayton) Chamberland
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