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Senior Process Optimization Specialist
7 hours ago
Job Overview:
Nordberg Medical is seeking a highly skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.
Key Responsibilities:
- Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device 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).
- Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
Requirements:
- Around 5-8 years of experience in process engineering, within the pharmaceutical or medical device industry with experience in at least Class III products.
- 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, ISO 13485, FDA 21, and other applicable regulatory requirements.
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