My client a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Offering innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
- Support DPM (Direct part marking) site critical project.
- Ensure delivery of all projects on time and on budget.
- Improve designs through projects.
- Work with team on product transfers from product development to manufacturing.
- Provide technical expertise, guidance and supervision during project phases.
- Continuously improve the manufacturing and test processes through a continuous improvement program.
- Review and/or develop and execute facility, process and equipment validations and risk management summaries.
- Review change controls for validation impact.
- Use knowledge of statistics to assist with validation developments and process improvements.
- Support Engineering and Manufacturing teams and lead investigations as required
- Liaising with suppliers for precision test fixture fabrication and modifications
- Responsible for regulatory testing, data analysis, and report generation for PMA submissions
- Assisting on CAPA investigations
- Design and development using CAD techniques and modelling and prototype building
- Hons Degree in Mechanical Engineering, or a related technical discipline.
- Qualification in Project Management is desirable.
- Working knowledge of materials (plastics, metals, etc)
- 2-3 years in a similar position
- Familiar with electronic and electro-mechanical systems manufacturing.
- Familiarity with the requirements of validating product and processes.
- Exposure to ISO-9000 and/or ISO-13485 series.
- Working knowledge of statistical analysis.
- Equipment and Process Validation experience desirable
- Excellent communication and skills – written, oral and pc.
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