The Team leader will manage all Engineering activities, employees, and projects, ranging from Design Transfer and cost reduction to production stability.
The Team leader will be a significant member of the Operations management team.
Job Description:
1. Manages the day-to-day activities of the Engineering team as well as the management and execution of teams projects against project plans and company goals.
2. Provides guidance and direction, as well as hands-on resource and project management, for all Engineering activities.
3. Optimizes the manufacturing lines, continuously support and improve efficiency, quality, and safety.
4. Analyse and resolve process issues, ensuring consistent and reliable production output.
5. Organize manufacturing validation activities for new and existing products to ensure product specifications and procedures are achieved.
6. Lead investigations of manufacturing deviations (NCMR) and process failures and identify root causes that will lead to applicable corrective actions.
7. Work closely with R&D on product deviations investigations and troubleshooting resulted from the production line.
8. Extending process and product Engineering controls to outsourced manufacturing of administration sets (single use sterile products), ensuring alignment with company standards and regulatory requirements.
9. Managing design transfer processes from design freeze to the implementation of stable and validated production line.
10. Lead Engineering changes (ECO) and process experiments.
11. Provide guidance on the Engineering workshop activities, including equipment/ fixtures (Jigs) purchasing, calibration and maintenance.
12. Collaborate with cross-functional teams, including R&D, manufacturing, quality, and supply chain, to implement process corrective actions and improvements.
13. Supporting the Quality and production departments as needed.
14. Proactively leads cost reduction initiatives and supports operational excellence projects.
Education: Bachelors degree in Mechanical Engineering/ Biomedical Engineering/ Industrial Engineering or a related field.
Job skills:
o At least 5 years of experience in Manufacturing Engineering, preferably in a medical devices company with multidisciplinary devices
o At least 3 years in a leadership role
o Extensive experience in manufacturing process controls and validation, statistical process control, and sustaining engineering within a regulated manufacturing environment
o A track record of successful process support and optimization
o Strong experience authoring and reviewing technical documentation, including validation protocols, reports, technical investigations and manufacturing work instructions
o Knowledge of FDA regulations, ISO standards (ISO 13485), and other relevant regulatory requirements
Computer Skills:
o Full control of all Microsoft Office applications
o SolidWorks (a plus)
Language skills: Fluent English (written and verbal)
Personality:
o Excellent communication and leadership abilities to influence teams and collaborate effectively across departments
o Entrepreneurial and results driven with a proven ability to deliver strong results and improve processes. Motivate and lead by example.
o Independent, organized, attention to details.
