Senior Mechanical Engineer

Independent Recruiters -  Leiden
30+ dagen geleden   |   52x bekeken

Functie omschrijving


  • Serve as the engineering approver for process development studies and validation documentation

  • Lead equipment and process improvements projects 

  • Identify, quantify, and implement opportunities to reduce cost of goods 

  • Responsible for performing and documenting activities for IQ, OQ and PQ 

  • Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items 

  • Work with vendors to procure new equipment and ensure new equipment and processes conform to EHS&S guidelines 

  • Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement

  • Provide the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Regulatory, Procurement, Manufacturing, and Environmental/Safety.

  • Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities.

  • Accountable for appropriate improvement and execution of process and validation activities at external suppliers as required. Support raw material and supplier qualifications

  • Provide project updates and presentations to all levels of the business.

  • Ensure all activities are carried out in accordance with appropriate internal and external Health, Safety & Environment procedures and safe working conditions and practices and supporting documents are in place. Observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility.

  • Maintain project documentation and files and, where appropriate, suggest improvements to systems and procedures.

  • Ensure all assigned activity is carried out in accordance with appropriate internal and external quality systems.

  • Engineering degree (Bachelor/Master) 

  • Mechanical background with up to 5 to 10 years in industry (Engineer) - with significant Experience in medical environment.

  • Candidates with experience in Automation / Software/ PLC’s/Machine Packaging required

  • Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements

  • Project management and project and resource prioritization

  • Strong time, budget, and program management skills

  • Demonstrated experience in the development and execution of project plans

  • Thorough working knowledge of the validation requirements for Medical Devices with demonstrated experience; generate and execute equipment, process, and computer system validation.

  • Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, C/E Matrix, pFMEA, fish bone diagrams, etc.

  • Candidates who have experience using MiniTab are preferred.

  • Good organization skills and results oriented

  • Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation. Ability to communicate across multiple levels in the organization

  • Demonstrated proficiency in regulatory compliance

  • Ability to work in a team environment

  • Fluent in English, Dutch will be a plus
Senior Mechanical Engineer for a world leader in the Biologics and Medical systems! The Engineering department is a young and enthusiastic team of engineering professionals, responsible for the long term planning, development, qualification and implementation of next generation manufacturing processes and automation technologies. Are you a mechanical engineer with significant experience in medical environment? Continue reading, this might be the next step in your career!


Vacature contactpersoon Jobbird
Joost Mooren

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