Significant opportunity for an energetic and talented electrical, systems, software, or biomedical engineer to develop medical devices that include high voltage and high frequency energy delivery systems. You would report to the Director of R&D at an expanding developer of innovative systems that have successfully treated thousands with life threatening cardiac arrhythmias.
This position, open to permanent or contract employment, reports to the Director of R&D. The job requires a self-starter who will play a key role developing product concepts and prototypes, and participate in all stages of the design, development, and regulatory approval of new products. Responsibilities include ideation and invention, solving unique technical challenges, management of suppliers and contract development partners and support of regulatory submissions. This broad and challenging role requires strong analytical and problem-solving skills and knowledge of electronic hardware and software. The engineer will work closely with senior management across cross functional groups and be a focal point for in-house knowledge of electronic systems.
Qualifications:
- BS or MS in Electrical, Systems, Software, Biomedical Engineering, or related disciplines.
- Successful medical device product development experience, with a minimum of two years in a commercial FDA regulated environment. Senior engineers are encouraged to apply; salary is commensurate with relevant skills and experience.
- Demonstrated ability to take projects from concept through product realization.
- Electronic prototyping, system integration, debug and verification are skills desired.
- Strong understanding of IEC 60601-1, 3.1 edition Safety and Essential performance.
- Knowledge of LabView strongly desired.
- Ability to effectively manage outsourced product development engineering.
- Strong written and verbal communication skills, with the ability to write clear reports, specifications, and proposals and effectively discuss them with R&D, Manufacturing, QA, Clinical, and Marketing team members.
- Working knowledge of regulatory requirements for medical devices.
- Exposure to the development of radio frequency ablation or electroporation systems, and/or complex systems with a catheter component for cardiology or electrophysiology are pluses.