JOB REQUIREMENTS:
Education: Degree in Mechanical / Production Engineering or equivalent.
Experience: minimum of 4 years relevant experience, preferably within Medical Device industry or other regulated environments.
Working knowledge of Product & Process validations essential.
Skills/ attributes:
Excellent engineering ability
Strong organisational ability
Self motivation and drive
Demonstrate a high level of responsiveness to internal customers (eg. production)
Communication- strong written, oral and presentational skills.
JOB TITLE: Manufacturing Eng II
MARKETING JOB TITLE: Manufacturing Engineer
DEPARTMENT: Biotools Engineering
REPORTING TO: Senior Engineer or Engineering Manager
SCOPE:
Reporting to the Senior Manufacturing Engineer, the Manufacturing Engineer II is primarily responsible for effectively implementing change management projects in one or more of the manufacturing areas.
DUTIES AND RESPONSIBILITIES:
1. Initiate, co-ordinate and complete assigned projects within the engineering department, using structured approach and detailed planning to deliver projects that meet or exceed stakeholder expectations and that are delivered Right First Time, safely, on schedule and within budget.
2. Complete Process / Product Validations within the department as they arise, in conjunction with Quality/Validation group.
3. Support Equipment Validations within the department as they arise, in conjunction with Quality/Validation group.
4. Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows.
5. Prepare & execute OQ / PQ protocols for process / material changes as needed.
6. Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
7. Liaise with operations and technician group to prepare plan for validation builds.
8. Co-ordinate the execution of OQ / PQ builds.
9. Prepare OQ / PQ validation reports and deviations as required.
10. Conduct process capability analysis using Minitab.
11. Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
12. Provide Technical/Engineering support manufacturing.
13. Lead and coordinate the troubleshooting of various manufacturing process issues.
14. Responsible for dealing with process, product and quality issues to achieve long term solutions.
15. Regular reporting of manufacturing process performance to relevant personnel. Use of OEE line performance tools to identify and address efficiency losses.
16. Support the training of production personnel on process and product principles.
17. Support the various groups: quality, validation, maintenance, EHS etc to achieve objectives.
18. Ensure compliance with GMP and Safety rules on new and existing equipment.
19. Lead and co-ordinate cost resolution projects year on year as per individual goals.
20. Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.
21. Thorough investigation of Quality and EHS issues using Root Cause Analysis methodology, and implementation of robust corrective and preventative actions to prevent recurrence.
22. Working Knowledge of the following would be an advantage but not a requirement
• Automated / Semi Automated assembly equipment.
• Injection moulding and mould tools.
• High precision Punch & Die Sets.
• Heat sealing, ultrasonic welding, leak testing, vision systems.
• OEE Line performance methodology.
• Minitab/ Lean 6 Sigma techniques
• Root Cause Analysis methodology
• Microsoft Excel to an advanced level
• AutoCAD.
Jordan
0799936279