- BS or MS in electrical engineering, biomedical engineering, or closely related engineering discipline.
- 12+ years professional experience in implantable medical systems, with 7+ years in a senior R&D leadership role.
- Successful experience working will multi-disciplinary, highly skilled engineering teams.
- Experience with implantable neuromodulation systems and related technologies.
- Deep knowledge of, and experience with, design controls and quality system practices.
- Excellent interpersonal, written, and verbal communication skills.
- General working knowledge in a wide variety of technical areas, including electronics, sensors, embedded systems, wireless communications, firmware, and application software, with expertise in at least one of these areas.
- Experience with preclinical testing and supporting regulatory submissions.
- Deep knowledge of ISO 14708-3, ISO 14971, ISO 13485, 21 CFR Part 820 and other industry standards applicable to an implantable neuromodulation system.
- Lead the design and analysis for an implantable neuromodulation system, encompassing an implantable neurostimulator, stimulation lead and external instruments. Analyze system requirements, interfaces, communications, and technologies.
- Develop and author the document deliverables for an implantable neuromodulation system, including system requirements, system design documents, system risk analyses, and system V&V testing.
- Lead system design reviews, document the results, track, and monitor action items.
- Manage Design History File.
- Work with senior technical team to define and accomplish development objectives.
- Support critical suppliers and development partners.
- Oversee development of Device Master Record.
- Provide system review of proposed documentation and associated product changes.
- Provide support and participate in company’s corrective and preventative action (CAPA) process.
- Provide detailed support for clinical studies and regulatory submissions.