Website Avivomed

REQUIREMENTS:

  • 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.

RESPONSIBILITIES:

  • 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‚Äôs corrective and preventative action (CAPA) process.
  • Provide detailed support for clinical studies and regulatory submissions.