· Lead projects in design and development of medical systems on time and on budget.
· Manage the creation of key design and development documentation that meets quality and regulatory requirements.
· Work closely with a multidisciplinary team (such as R&D, Manufacturing, Service, Clinical, Quality, Regulatory and Marketing departments)
· Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
· Manage GMP systems, including production quality assurance procedures, pre-clinical testing programs and post-production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
· Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and international regulations.
· Minimum of Bachelor’s in engineering (Mechanical, Electrical or Systems preferred).
· Minimum of 5 years in medical device project management required.
· Experience managing projects for European CE Mark, China NMPA and US FDA is preferred.
· Experience with Design Control procedures and requirements engineering.
· Experience developing systems in compliance with IEC (62304, 60601) and other industry standards for electronic medical device equipment is preferred.
We would like to invite interested applicants to apply.
Registration No: 12C6253
License No: R22108919
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- Biomedical Engineering
- Clinical Works
- Document Management Systems
- Financial Management
- Good Manufacturing Practices