Medical Device Engineering Manager

10 hours ago


Stockholm, Stockholm, Sweden Nordberg Medical AB Full time
Job Role Summary

As a Senior Production Process Engineer, you will play a crucial role in leading and supporting the development, optimization, and validation of manufacturing processes for our medical devices. You will work closely with cross-functional teams to ensure compliance with medical device regulations and standards.

Key Responsibilities:
  • Process Improvement: Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
  • Equipment Maintenance: Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
  • Regulatory Compliance: Ensure all production processes comply with medical device regulations and standards, including FDA, ISO, and other applicable guidelines.
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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