Manufacturing Process Development Engineer

1 week ago

Stockholm, Stockholm, Sweden Nordberg Medical Full time
About the Role

We're looking for a skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.

  • 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).
Key ResponsibilitiesProcess Design and Development:
  • Design, develop, and optimize 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.
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.
Qualifications
  • 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.
Why Nordberg Medical?
  • Impact: You'll have a unique chance to join us at an early stage, during an extensive expansion of both product range and volume.
  • Continuous Development: We are committed to fostering your professional growth through ongoing training and development opportunities.
  • Entrepreneurial Environment: Join a global, inclusive team where innovation and creativity are actively encouraged.

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