Job Description
Position Summary
Principal Responsibilities
1. As technical lead and project manager which responsible to lead process improvement for assembly process activities, inclusive of the manual assembly, semi automated and fully automated processes and equipment
2. Establish a holistic approach and road map for process development on new project and existing process improvement opportunity.
3. Manage a portfolio of projects ensuring effective allocation of resources and tracking the progress update on individual project
4. Coordinate technical training for team members upon SME development.
5. Support new products, transfers, and existing production process development.
6. Research, investigate, test and develop new manufacturing process technology including manufacturing and testing equipment thus provides improvement for current process.
7. Drive technical project to completion by ensuring overall design of the equipment meets requirements, overseeing project, and maximizing project resources to ensure milestones are met on a timely basis
8. Manage resources to ensure the successful completion of an assigned project.
9. Manage the project to keep it on track and within approved budget. Ensures technical decisions are appropriate to meet all requirements and cost-effective for manufacturing requirements.
10. Identifies potential for process or quality improvements during development of new process, product transfer or new project introduction.
11. To ensure the implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
Education / Experience Requirements
Qualification :
Bachelor’s Degree in Mechanical Engineering or equivalent technical discipline, or an advanced degree, or equivalent work experience.
Experience :
a) Minimum 8 years working experience, preferably in a Medical Device / Manufacturing Industries and demonstrated expertise or with in-depth knowledge in relevant Engineering discipline and Project Management
b) 3 years project leadership experience, across the full spectrum of product / process development. Experience as the lead for manufacturing process development on medical device and proficient in technical writing of protocols and reports. Familiar with medical terminology, medical / clinical research methodology. Significant experience in product verification and validation testing, new product development of the medical device and rapid prototyping.
c) Recognized as an influential business partner. Has strong facilitation skills and the ability to communicate effectively to varied audiences to gain support or resolve issues. Makes effective presentations on complex or sensitive topics to top management and/or other key stakeholders.
d) Advanced interpersonal and communication skills, both written and verbal, with the ability to work as a team player and team builder. Highly self-motivated, minimal day to day supervision. Excellent collaborator and able to quickly establish effective relationships with people across all levels.
e) Stage-gate product / process development process experience and ability to leverage and/or engage others to accomplish projects
f) It will be an advantage to have relevant experience from the Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485.
g) Ability to Influence scientific thinking and direction of projects
h) Proficient in manufacturing process control with strong analytical and statistical skills