Production Process Lead

7 hours ago


Stockholm, Stockholm, Sweden Nordberg Medical AB Full time
Job Overview

We are seeking a highly skilled Senior Production Process Engineer to join our team at Nordberg Medical AB. The successful candidate will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our medical devices.

Key Accountabilities:
  • Process Validation: Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
  • Documentation and Compliance: Ensure all production processes comply with medical device regulations and standards, including FDA, ISO, and other applicable guidelines.
  • Collaboration with Cross-Functional Teams: Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
Requirements:
  • 5-8 years of experience in manufacturing engineering or process engineering, preferably within the medical device, pharmaceutical, or regulated healthcare industry.
  • Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
  • Experience of freeze drying and sterilization processes, preferably EtO and E-beam.
  • Proficiency in process design and validation methodologies, including IQ/OQ/PQ.
  • Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulatory requirements.
  • Experience with statistical process control (SPC), Design of Experiments (DOE), and root cause analysis.
  • Familiarity with CAD software and process simulation tools.
  • Advanced skills in data analysis and reporting.
  • Fluency in English (verbal and written).


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