Johnson & Johnson Robotics and Digital Solutions (RAD) group is seeking an engineer to lead the effort to test their surgical robotic system for compliance with international standards for Medical Device electromagnetic compatibility (EMC) and Wireless Intentional Radiator licensing, ensuring adherence to Quality and Regulatory objectives.
Requirements
- Solid understanding of all applicable 60601 and related standards across all global regions including IEC 60601-1-2, FCC CFR, Title 47, Part 15, Subpart A, B, & C, Radio Equipment Directive (RAD) (2014/53/EU), and Japan (MIC) Radio Laws.
- Knowledge of equipment, tools, and procedures used in evaluation and testing of systems for compliance with EMC standards.
- Experience with Quality risk management processes for medical devices including ISO 14971.
- Experience designing electronics in safety-critical applications.
- Experience in complex capital medical device equipment.
- Experience in signal integrity and RF Design.
- Experience with python, Linux, or other high level programming languages.
Responsibilities
- Define IEC-60601 executional strategy across geographies and commercial releases.
- Support Onsite EMC testing in RF pre-compliance lab and External EMC Testing at external compliance laboratories for entire robotic system.
- Develop test and verification methods for electromagnetic compatibility across platform.
- Perform negotiation of test strategy and execution with NRTLs in support of program objectives.
- Advise design engineering on EMC guidelines and perform design reviews across the entire robotic platform.
- Support EMC troubleshooting and iterative EMC design improvements.
- Generate isolation diagrams, risk documentation, reports, and 60601 related documentation.
Other
- Bachelors in Electrical Engineering (or related field) with 8+ years, or Advanced Degree in Engineering or related field with 6+ years of industry experience.
- Experience working with fielded medical device products and experience negotiating with NRTLs.
- Proven track record providing technical direction, mentorship and expertise to others.
- Technical leadership and management of projects including external contractors, partners and suppliers.
- Candidates must be self motivated, independent and have an eagerness to learn and work as a team, and a desire to thrive in a very fast paced environment.
