Engineer, Process

Process Engineer

Fixed-term contract for 2 years

Job responsibilities

• Create and execute validation strategies for medical device assembly processes and equipment, including writing validation protocols and reports (IQ, OQ, PQ), executing process tests, and analyzing the resulting data from validation activities
• Manage external equipment vendors through the process of machine design, procurement, and installation of new manufacturing equipment
• Ensure all Health, Safety and Environment requirements are met and new standards are implemented
• Serve as the process and equipment engineering to support manufacturing on a day to day basis
• Provide engineering input to solve complex manufacturing process problems in the medical assembly environment, including a continuous focus on plant equipment and manufacturing processes to achieve cost and cycle time savings
• Follow process performance metrics and initiate appropriate actions
• Take the responsibility for the technical know-how of operators and technicians
• Support closure of NRs, CAPAs, audit observations, ergonomics and safety related action items.
• Lead Lean Manufacturing studies to improve assembly processes and to introduce new processes and equipment
• Critically assess, improve and implement medical manufacturing processes to achieve cost reductions and quality improvements in line with agreed targets and priorities of Business Unit.

• Engineering Degree (automation/ mechanical / micromechanical background) from an accredited technical or manufacturing engineering program is required

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

• Process Excellence Six Sigma and/or Lean certification is desirable

• Experience in manufacturing and equipment engineering in the medical device industry will be appreciated

• Project management experience to support equipment development and introduce them into Manufacturing

• Experience required in leading manufacturing process initiatives to achieve quality improvements and cost reductions

• Resistance to stress

• 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

• Fluent in French and English

  
  

Technical Competencies:

• Mechanical Engineering
• Electrical Engineering
• Validation, QA/RA procedures
• Problem Solving Skills
• Health & Safety Knowledge

Authorities:

• Validations
• Adaptiv Approvals & Submission

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