Staff manufacturing process Engineer Mentor Medical Systems B.V.-00000PJA
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)
• Academic 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
What do we offer you?
We offer a dynamic international working environment with attention to personal development. We also offer a competitive salary and good benefits, such as a sports fee, ADV days and a good pension scheme.
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 via the link below.
If you have any questions regarding this position please contact Karine van Til, Recruiter: ktil@its.jnj.com
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Mentor Medical Systems, B.V. (8808)
Job Function: Engineering (Generalist)
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)
• Academic 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
What do we offer you?
We offer a dynamic international working environment with attention to personal development. We also offer a competitive salary and good benefits, such as a sports fee, ADV days and a good pension scheme.
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 via the link below.
If you have any questions regarding this position please contact Karine van Til, Recruiter: ktil@its.jnj.com
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Mentor Medical Systems, B.V. (8808)
Job Function: Engineering (Generalist)