Senior Manufacturing/Process Engineer(Job Number: 00000TKT)
Description
Department description:
The Engineering department is responsible for the long term planning, development, qualification and implementation of next generation manufacturing processes and automation technologies.
Responsibilities:
- Serve as the process and equipment engineering to support manufacturing
- Serve as the engineering approver for process development studies and validation documentation when authorized
- Lead equipment and process improvements projects
- Responsible for performing and documenting activities for IQ, OQ and PQ
- Follow compliance and HSE policies and guidelines
- Identify, quantify, and implement opportunities to reduce cost of goods
- 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 HSE guidelines
- Technical writing, data analysis, data tracking and trending
- Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units.
- Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement
- Lead technical investigations and feasibility studies as required for specific projects/tasks.
- Provide technical information on appropriate areas to all functions within the business.
- Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies.
- 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
- Follow process performance metrics and initiate appropriate actions
- Take on the responsibility for the analysis and disposition of process related defects
- Take the responsibility for the technical know-how of operators and technicians
- 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.
Qualifications
Profile (education level, experience, competences)
- Engineering degree
- Mechanical background with up to 8 to 10 years in industry (Engineer) - with significant Experience in medical environment.
- Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements
- Understanding of process variability and process control
- Lean and/or Six Sigma
- 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.
- Demonstrated ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities.
- 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.
- Proficiency with Microsoft Office and a working knowledge of statistical software is required. Candidates who have experience using MiniTab are preferred.
- 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
- Demonstrated proficiency in regulatory compliance
- Ability to work in a team environment
- Fluent in English, Dutch will be a plus
More information:
Position: Full time / 100%
Start date: As Soon As Possible
Ability to travel up to 10% average (project / task based)
Are you interested in this new challenge?
Please apply online
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Mentor Medical Systems, B.V. (8808)
Job Function: Process Engineering
Description
Department description:
The Engineering department is responsible for the long term planning, development, qualification and implementation of next generation manufacturing processes and automation technologies.
Responsibilities:
- Serve as the process and equipment engineering to support manufacturing
- Serve as the engineering approver for process development studies and validation documentation when authorized
- Lead equipment and process improvements projects
- Responsible for performing and documenting activities for IQ, OQ and PQ
- Follow compliance and HSE policies and guidelines
- Identify, quantify, and implement opportunities to reduce cost of goods
- 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 HSE guidelines
- Technical writing, data analysis, data tracking and trending
- Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units.
- Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement
- Lead technical investigations and feasibility studies as required for specific projects/tasks.
- Provide technical information on appropriate areas to all functions within the business.
- Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies.
- 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
- Follow process performance metrics and initiate appropriate actions
- Take on the responsibility for the analysis and disposition of process related defects
- Take the responsibility for the technical know-how of operators and technicians
- 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.
Qualifications
Profile (education level, experience, competences)
- Engineering degree
- Mechanical background with up to 8 to 10 years in industry (Engineer) - with significant Experience in medical environment.
- Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements
- Understanding of process variability and process control
- Lean and/or Six Sigma
- 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.
- Demonstrated ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities.
- 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.
- Proficiency with Microsoft Office and a working knowledge of statistical software is required. Candidates who have experience using MiniTab are preferred.
- 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
- Demonstrated proficiency in regulatory compliance
- Ability to work in a team environment
- Fluent in English, Dutch will be a plus
More information:
Position: Full time / 100%
Start date: As Soon As Possible
Ability to travel up to 10% average (project / task based)
Are you interested in this new challenge?
Please apply online
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Mentor Medical Systems, B.V. (8808)
Job Function: Process Engineering