Senior Manufacturing Engineer

7 hours ago


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

Nordberg Medical AB is seeking a skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our medical devices.

Key Responsibilities:
  • Process Design and Development: Lead the design, development, and optimization of manufacturing processes for new and existing medical device products.
  • Collaboration with Cross-Functional Teams: Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
  • Equipment Management: 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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