Staff Electrical Compliance Engineer - R&D Robotics

Staff Electrical Compliance Engineer

Johnson & Johnson, Robotics and Digital Solutions (RAD) group is recruiting for a Staff Electrical Compliance Engineer located in Santa Clara, CA.

At Johnson & Johnson Robotics and Digital Solutions, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.

Johnson & Johnson MedTech is developing a robotic surgical platform that will set a new standard for the modern OR and transform the surgical experience. OTTAVA is designed as a multi-specialty soft-tissue surgery robot, activating the benefits of AI/ML, connecting health data inside the operating room and out.

The Hardware Team in the RAD group is a diverse group of highly motivated engineers who are passionate about architecting, developing and prototyping the next generation, groundbreaking robotic platforms. We want you to join our team and be part of the success of our mission.

Overview

We are seeking an engineer that is passionate about problem solving and ready to work across the broader R&D Team in support of IEC 60601 device compliance. In this role, you will lead the effort to test our surgical robotic system for compliance with international standards for Medical Device electromagnetic compatibility (EMC) and Wireless Intentional Radiator licensing. This role includes providing design input guidance, test planning and execution, and test report (TRF) generation to support JnJ Quality and Regulatory objectives. Testing will be performed both internally and outside NRTL accredited testing laboratories providing evidence assuring compliance with necessary relevant standards.

This position places an emphasis on working closely with a multi-disciplinary engineering team to develop complex hardware designs. 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. You are expected to demonstrate advanced electrical engineering knowledge, be able to independently resolve approaches to technical problems, and have communication capabilities vital to communicate broadly across engineering teams.

Core Job 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.
• Supporting regulatory submissions across geographies and clinical indications.

Qualifications

Required Knowledge/Skills, Education, And Experience:

• Bachelors in Electrical Engineering (or related field) with 8+ years, or Advanced Degree in Engineering or related field with 6+ years of industry experience.
• 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.
• Experience working with fielded medical device products and experience negotiating with NRTLs.
• 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.
• Proven track record providing technical direction, mentorship and expertise to others.
• Technical leadership and management of projects including external contractors, partners and suppliers.

Preferred Knowledge/Skills, Education, And Experience:

• 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.
• Experience with Altium Designer.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

The anticipated base pay range for this position is $141,000.00 to $227,700.00.