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Process Development Director
6 hours ago
Job Description:
We are seeking a highly skilled Senior Production Process Engineer to join our team at Nordberg Medical. As a key member of our production department, you will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.
Responsibilities:
- Lead the design and development of manufacturing processes for new and existing implantable medical device products.
- Collaborate with cross-functional teams to ensure that all production processes comply with regulatory standards and quality requirements.
- Develop 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.
What We're Looking For:
- 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.
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