Website Avivomed
REQUIREMENTS:
- Advanced degree in electrical engineering, biomedical engineering, or closely related engineering discipline.
- 15+ years professional experience in medical technology, with 10+ years in a senior R&D leadership role in implantable medical systems.
- Successful management experience, including building and mentoring highly skilled engineering team across multiple engineering disciplines.
- Excellent leadership, interpersonal, written, and verbal communication skills.
- Experience in identifying, recruiting, and hiring technical employees, including engineers and technicians.
- Proven track record of developing implantable technologies and delivering according to company objectives.
- Knowledge in a wide variety of technical areas, including custom integrated circuits, microelectronics, sensors, embedded systems, firmware, wireless technologies, and application software.
- Deep knowledge of design controls, human factors, usability engineering, and risk management practices.
- Experience with preclinical testing, clinical evaluation and supporting regulatory submissions.
- Experience with analyzing and generating intellectual property; including collaboration with IP counsel.
- Deep knowledge of ISO 14708-3, ISO 14971, ISO 13485, 21 CFR Part 820, and other industry standards applicable to an implantable neuromodulation system.
RESPONSIBILITIES:
- Formulate and lead the strategy for development of an implantable neuromodulation system, encompassing an implantable neurostimulator, stimulation lead and external instruments.
- Create processes and practices for R&D in compliance with recognized industry standards and quality system.
- Define, hire, and lead the R&D team, including managers, engineers, and technicians across multiple technical disciplines.
- Locate, secure, and manage critical development partners. Manage business relationship and project activities.
- Work with senior management team to define and accomplish company objectives. Provide detailed support for clinical and regulatory affairs.
- Assist in supporting company’s Information Technology infrastructure.
- Work with R&D team and IP counsel to develop intellectual property portfolio.
- Provide assistance to CEO with Scientific and Medical Advisory Board (SMAB), Board of Directors and investor relations.