Process Engineering Lead

19 hours ago


Stockholm, Stockholm, Sweden Nordberg Medical Full time

At Nordberg Medical, we are expanding our manufacturing capabilities and seeking a highly skilled Process Engineering Lead to join our team. This role will play a crucial part in the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices.

The ideal candidate will have around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry, with expertise in at least Class III products. A bachelor's degree in engineering or a related field is required, and a master's degree is preferred.

Key Responsibilities:

  • 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.

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.

Required Experience & 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.

We Offer:

  • A unique opportunity to join us at an early stage, during an extensive expansion of both product range and volume.
  • Ongoing training and development opportunities to foster your professional growth and ensure you have the resources and support needed for continuous learning and success.


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