
Manufacturing Process Lead
2 days ago
As a key member of Nordberg Medical's manufacturing team, you will be responsible for leading the development, optimization, and validation of production processes for our implantable Class III medical devices. With a strong focus on quality and efficiency, you will work closely with cross-functional teams to implement advanced manufacturing techniques and drive continuous improvement initiatives. Your expertise in process design, documentation, and validation methodologies will ensure compliance with regulatory standards.
- Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
- Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
- Process Design And Development
- Process Validation And Qualification
- Continuous Improvement And Optimization
- Regulatory Compliance And Documentation
- Equipment Management And Maintenance
The ideal candidate will have around 5-8 years of experience in process engineering, preferably within the pharmaceutical or medical device industry, with a strong understanding of GMP, ISO13485, and FDA 21. A bachelor's degree in engineering is required, and a master's degree is a plus. Proficiency in statistical process control, Design of Experiments, and root cause analysis is beneficial.
Nordberg Medical offers a dynamic and inclusive environment where innovation and creativity are actively encouraged. We are committed to fostering your professional growth through ongoing training and development opportunities. If you are a motivated and analytical individual with a passion for process improvement, we encourage you to apply for this exciting opportunity.
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