Technical Manager

Position Summary

Principal Responsibilities

1. Successful completion of the Program on schedule and on Budget.
2. Management of the program plan including scope, schedule, cost, technical, resource and risk management.
3. Establish and maintain detailed technical plans, estimates and schedules.
4. Program tracking and reporting (cost, schedule, and milestone accomplishments), using Project scheduling, reporting and financial management tools as appropriate.
5. Ensure the following deliverables are achieved as per the Teleflex procedure TG-000080
6. Identifying any risks and develops mitigation plans, and communicating these to the Program Director.
7. To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
8. Ensure Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD93/42/EEC, MDR, ISO 13485 and other relevant Standards.
9. Lean out the manufacturing process for all products involved in the program
10. All technical aspects (equipment, facility, etc.) of the project and to ensure that the products are analysed against all appropriate standards utilizing appropriate techniques and documentation.
(Sterility Assurance involvement is required during design/development phase for new controlled environment or cleanroom built to accommodate the transfer.)
11. Manage all equipment which requires calibration are carried out and maintained
12. Developing detailed Process Map for the processes, identifying key performance criteria, quality attributes and equipment, etc.
13. Creating a Transfer Validation Plan (TVP) that defines the validation work statement for the transfer.
14. Update the Sending and Receiving Site Validation Master Plans to reflect transfer activities.
15. The review of the condition and capability of the manufacturing processes to produce to key product specifications, equipment, fixtures, and test equipment needed for the successful manufacture of the product.
16. Technical assessment and screening of the product and or process is to be verified (either directly or indirectly) against the current manufactured product and/or Product Performance Specifications or equivalent technical documentation (i.e., DHF, DMR).
17. Conduct engineering studies for key product outputs.
18. Establish process input to output relationships prior to move and validation if identified by the teams.
19. In cases where Statistical Process Control (SPC) is not deployed, it may be prudent to collect SPC data to facilitate the receiving site’s Quality Control Plan. This is not mandatory but is suggested for those critical processes not under SPC.
20. Identification of special processes that will require validation or verification.
21. Reviewing, revising, or generating the necessary documentation on equipment, tooling, specification, drawings, etc.
22. Working with Quality on the validation of equipment, processes.
23. Review Process Failure Mode Effect Analysis (PFMEA) and update if the review requires changes.
24. Work with Technical Engineer, Process Engineers and Quality Engineer in executing the Validation protocols for facility validation, equipment validations, operation qualification validation and process qualification validations
25. Ensure that in-process inspection and testing equipment’s are in place and meets the testing requirements
26. Review all history for customer complaint, non-conformance such as NCR, SCAR, CAPA, Recall, EIF of all products involved in the program.

Education / Experience Requirements

Qualification:
Minimum education bachelor’s degree in a technical field (Engineering or Science).

Experience:
At least 10 years’ experience in manufacturing / engineering environment.

Specialized Skills / Other Requirements