Lead Electrical Engineer

THE COMPANY

Our client is a high-growth medical device company that is revolutionizing the industry with first-of-its-kind technology for portable hemodialysis. This is a public company disrupting the industry through their innovative design. Their manufacturing site is in Tijuana, B.C. Mexico. And our client is looking for a motivated Lead/Staff Electrical Engineer to join the Hardware Engineering Organization to work on product development and sustaining activities for technically complex hemodialysis systems. In addition, this position will also be leading a team of Electrical Engineer(s). Areas of responsibility include the design of hardware components; generating specifications; system and subsystem integration; and verification and validation efforts in accordance with standards and requirements. The individual will be a hands-on technical lead and must be able to design electrical circuits, write detailed electrical specifications, test procedures/reports, generate design output files, and work within the requirements/regulations of our client’s quality system.

THE POSITION

Essential Job Functions and Responsibilities:

• Design and develop electrical systems and architectures from board to system level spanning a broad range of disciplines, i.e., digital, analog, power, packaging/thermal, and firmware.
• Provides hands-on technical and non-technical leadership to team members.
• Facilitate board bring-up, test, and debug of newly designed electrical hardware.
• Work directly with an outsourced engineering design firm for PCBA layout and manufacture, specifying requirements relating to analog instrumentation, digital and power circuits including power derating and EMC.
• Firmware development in C/C++ including the ability to bring-up new interfaces (sensors, motor controllers etc.) on ARM/Cortex-M processors.
• Collaborate with external consultants/contractors to specify, implement and test designs.
• Participate in design reviews and design FMEA analysis.
• Develop specifications, system protocols, test protocols for design verification activities and compliance testing in a regulated environment.
• Act as a technical lead for subsystem projects with minimal guidance and act as a mentor to emerging engineers. Define priorities and execute them on the same.
• Perform hardware testing for medical safety and EMC standards such as IEC60601, CISPR22, ISO for safety and EMC compliance in a regulated environment.
• Communicate status, plans to the multi-functional engineering and program management teams.
• Interface with operations, quality, regulatory, clinical affairs, outside consultants and vendors to ensure compliance with internal and external policies and procedures.

THE CANDIDATE

Required Qualifications:

• B.S. in Electrical Engineering (or similar); Master’s preferred.
• Minimum of 5 to 8 years’ experience in electrical engineering product development experience with at least 2 years in projects for medical applications preferred.
• Experience developing electrical systems in a cross-functional team environment.
• Excellent analytical and problem-solving skills.
• Able to travel up to 15% of time.
• Valid US Visa.
• Fluent in English and Spanish.

Desired Qualifications:

• Experience with compliance testing (EMC/EMI/Safety).
• Firmware design experience.
• Highly regulated industry experience like medical devices, automotive, appliances, 
• Excellent organization, documentation, and written/verbal communication skills.
• Experience with the generation, review, release, and understanding of formal engineering drawings and documents required for the fabrication and assembly.
• Experience working with vendors and contract manufacturers for fabrication and assembly.
• Experience with the use of laboratory instruments and tools (e.g., DMM, mixed signal oscilloscope, logic analyzer, spectrum analyzer, and network analyzer).
• Ability to work in a fast-paced environment with strong collaboration skills.
• Strong team leadership skills and the ability to work independently.