DUTIES AND RESPONSIBILITIES:
- Lead projects in design and development of medical systems on time and on budget.
- Plan project schedule and manage the budget for project expenditure.
- Effectively communicate tasks, timeline, budget and progress with management and the team.
- 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) to coordinate R&D and pilot production of new products.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Thorough working knowledge of quality management systems that are ISO 13485 certified.
- Oversee outside vendors and consultants as required.
- 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. Especially Europe, China and the United States.
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
- Minimum of Bachelors 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.
- Project Management Professional (PMP) Certification a plus
- Excellent written and verbal communication skills.
- Proven ability of analytical problem solving and troubleshooting.
- Experience with Design Control procedures and requirements engineering.
- Risk management (risk analysis, FMEA) experience required.
- Strong track record of technical leadership and working in cross-functional teams.
- Experience developing systems in compliance with IEC (62304, 60601) and other industry standards for electronic medical device equipment is preferred.
- Thorough working knowledge of quality management systems that are ISO 13485 certified.