Senior Production Process Engineer Leader
7 days ago
Nordberg Medical seeks a seasoned professional to join their team as Senior Production Process Engineer. As a key member of the organization, you will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for implantable Class III medical devices.
Key Responsibilities- Process Design and Development:
- 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 Validation and Qualification:
- Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
- Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.
- Analyze and document validation results, addressing any deviations or non-conformances.
- Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
- Continuous Improvement and Optimization:
- Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
- Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
- Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and project timelines.
- Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
- Collect and analyze production data to monitor process performance and identify areas for improvement.
- Generate reports, metrics, and presentations for management, summarizing process performance, validation activities, and improvement initiatives.
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