Line Engineer

Location Leiden
Discipline: Medical Device
Contact name: Isla Littlewood

Contact email: i.littlewood@panda-int.com
Job ref: 18871
Published: about 1 month ago

We are searching for a Line Engineer for one of our top Medical Devices clients in Leiden, NL!

Description: Designs comprehensive engineering activities to develop and implement effective, high-quality processes and design guidelines for dissemination throughout the division. Provides complex design reviews and feedback for improvements in manufacturability. Develops equipment, materials, and process performance requirements. Performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at effective costs. Designs experiments and capability studies, develops process specifications, and designs and procures process tooling. Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods. Communicates and monitors process and material quality targets. Measures performance to targets and implements remedial actions as instructed. Develops process documentation and training materials for new processes, materials, and equipment.

Responsibilities:

  • The Line Engineer participates in NPI processes and supports the introduction of new equipment and / or systems.
    • Testing new equipment and / or systems in consultation with MPS Process
    • Ensuring adequate documentation for the equipment (SOPs and Work Instructions)
    • Provide training for manufacturing operators in the correct use of the equipment
    • Ensuring the qualification of the equipment and, if necessary, validation of supporting processes (such as cleaning).
  • Ensure that the department works according to the required standards (cGMP, EHSS and process excellence) and drive its continuous improvement.
  • Follows the CREDO and stimulates empowerment.
  • Taking care of the maintenance of this equipment and / or systems, including addressing (acute) process disruptions; Maintains and performs basic repairs on equipment as needed. Schedules maintenance and/or repairs on equipment as directed.
  • Improving equipment and / or systems. All activities must comply with the requirements of cGMP and the EHS & S guidelines.
  • Responsible for communicating business related issues or opportunities to line engineers and engineering.
  • Responsible for an effective communication between different locations, customers, contacts and other internal/external departments.
  • Ensure Failure Mode Effects Analysis (FMEA), Process Control Plans (PCP), Failure Modes Effects and Criticality Analysis (FMECA), and Process Specifications exist, are current, and effective for assigned areas.
  • Understand Yield for all processes and identify/execute project to improve it.
  • The Line Engineer performs Periodic Review of processes.
  • Handles deviations independently.
    • Leading a research team if necessary.
    • Manage the NCR’s and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for non-conformances.
    • Conducting the root cause investigation.
    • Performing the product impact analysis.
    • The identification of corrective and / or preventive measures.
    • Handling the documentation associated with the deviation.
  • Acts as an SME for processes for which he / she is responsible.
  • Leads improvement processes, handles change controls independently.

 

Your profile:

  • Bachelor’s degree, with 4 years of relevant experience; in Medical device industry or medical field.
  • Experience with Lean (Greenbelt) or Six Sigma is required.
  • Verbal and written communication skills in English and Dutch (English must, Dutch preferred).
  • Demonstrated knowledge of manufacturing principles and practices, and procedures.
  • Computer skills in relation to usage to automation software such as Excel, Windows, ERP software.
  • Ability to work cooperatively with coworkers.
  • Six sigma and process excellence tools/methodologies.
  • Fulfilled the training to obtain full VCA certification
  • Understands and uses the methodology of TWI
  • Knowledge of automation and the associated procedures to enable him / her to assess whether improvements are necessary and the automation for his / her equipment meets current standards.
  • Familiar with the CGMP requirements insofar as these relate to his / her work.
  • Familiar with the EHS & S requirements insofar as these relate to his / her work.
  • Able to identify continuous improvements in (work) processes and to implement these.
  • Soft skills: effective communication, open to giving/receiving constructive feedback, takes initiative, driven, organized, stress-resistant

 

Practicalities:

  • 40 hours/week
  • On-site
  • Location: Leiden
  • Initial contract 6 months with option for extension
  • Start date: May 2022

If interested, please send your CV to  Isla Littlewood at i.littlewood@panda-int.com, or contact +31 20 20 44 502 for more info.