Position Overview

Outset Medical is looking for a motivated Lead/Staff Electrical Engineer to join the Hardwar Engineering Organization to work on product development and sustaining activities for technically complex hemodialysis systems. In addition, this position will also oversee 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 Outset’s quality system.

 

    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 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.

 

Required Qualifications:

S. in Electrical Engineering (or similar); Master’s preferred. Minimum of 8 years’ experience in electrical engineering product development experience with at least 2 years in projects for medical applications. Experience developing electrical systems in a cross-functional team environment. Excellent analytical and problem-solving skills.

 

Desired Qualifications:

Experience with compliance testing (EMC/EMI/Safety). Firmware design experience. 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.