
Senior Production Engineer
2 days ago
Nordberg Medical is seeking a highly experienced Senior Production Engineer to lead the development, optimization, and validation of production processes for our implantable Class III medical devices. As a key member of our manufacturing team, 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).
- Around 5-8 years of experience in process engineering, preferably within the pharmaceutical or medical device industry.
- Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
- Proficiency in process design, documentation, and validation methodologies, including IQ/OQ/PQ.
- Strong understanding of GMP, ISO13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
Nordberg Medical offers a unique opportunity to work with a global company dedicated to providing innovative solutions for the medical device industry. 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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