Engineering Process Optimization Specialist

4 days ago


Stockholm, Stockholm, Sweden Nordberg Medical AB Full time

Nordberg Medical AB seeks a highly skilled Engineering Process Optimization Specialist to lead and support the development, optimization, and validation of manufacturing processes for our medical devices. This role involves scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques.

This position requires strong analytical thinking, attention to detail, effective communication skills, and collaboration abilities.

About the Job

The ideal candidate will have a deep understanding of manufacturing processes and be able to analyze and optimize them to improve efficiency and product quality.

Key Responsibilities
  • Lead the design, development, and optimization of manufacturing processes for new and existing medical device products.
  • Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and 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 Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for new and modified manufacturing processes.
  • Evaluate and ensure validation protocols align with regulatory standards (e.g., ISO 13485, GMP, 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.
Qualifications
  • Around 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.


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