Process Development Lead

9 hours ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time
Transform Your Career with a Leadership Role

Nordberg Medical's implantable Class III medical devices require exceptional engineering expertise to ensure their quality and safety. As Senior Production Process Engineer, you will oversee the development, optimization, and validation of manufacturing processes, driving continuous improvement initiatives while maintaining regulatory compliance.

Responsibilities Include

  • Design and Development:

    • Leads the creation of efficient, scalable, and compliant manufacturing processes for new and existing implantable medical devices.
    • Collaborates with cross-functional teams to implement advanced manufacturing techniques and drive process improvements.
  • Validation and Qualification:

    • Conducts process validation activities, ensuring adherence to regulatory standards and facilitating effective execution to meet quality requirements.
    • Ensures that manufacturing equipment is properly maintained, calibrated, and functioning within established parameters.
  • Continuous Improvement and Optimization:

    • Leads and executes continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
    • Analyzes and addresses process failures or deviations, implementing corrective and preventive actions to prevent recurrence.
  • Regulatory Compliance and Documentation:

    • Ensures compliance with relevant regulations and standards, preparing and reviewing comprehensive documentation as required.
    • Provides technical support and documentation during audits and regulatory inspections.
  • Equipment Management and Maintenance:

    • Collaborates with maintenance and equipment teams to ensure optimal performance and reliability of manufacturing equipment.
    • Supports the installation and validation of new equipment, ensuring its compatibility with established processes and regulatory standards.


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