Position Overview

The Manager of Electrical Engineering will be responsible for overseeing a team of Electrical Engineers to research, design, develop and sustain electrical and control systems for technically complex hemodialysis systems. 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 manager 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 development of electrical systems across a broad range of disciplines, i.e., digital, analog, power, packaging/thermal, and firmware for the control of a complex fluid and blood handling system. Provide Develop embedded electrical designs that control variety of sensors and actuators including valves, heaters, flow controllers and pumps. Develop embedded electrical designs to drive displays, user inputs devices, and wireless peripherals. Design and development of electrical systems using tools and techniques including schematic capture, analog circuit and digital logic simulation, worst case component tolerance analysis, power derating, and reliability prediction. 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. Lead troubleshooting and root cause analysis of system electronics and provide solutions to design issues. Architect electrical designs to meet the requirements of the applicable 60601 series of standards. Specify and design wiring harnesses and interconnect assemblies applying applicable standards. Specify, design, construct and execute tests for electronic circuits and systems. Exercise a high level of initiative in identifying and rectifying electrical issues before actual standards testing. Perform worst case analysis to assure proper specification of components. Identify and implement cost reduction opportunities for the existing electrical architecture. Work closely with systems, software, and mechanical engineering to assure conformance to system requirements. Directly participate in and assist in development of electrical requirements for the system. Apply a high degree of initiative to understanding overall system objectives and proactively seek solutions to potential technical challenges. Confirm system capabilities by designing and performing feasibility and testing methods. Defines teams’ objectives and ensures they are consistent with strategic and operational objectives of the business. Provides hands-on technical and non-technical leadership to team members. Ensures project schedules are met, deliverables executed within the budgetary constraints of the business, and the organization is well-informed of project progress (i.e. at project update meetings, through technical and/or design reviews, etc.). Actively and independently leverages cross-functional relationships to ensure project objectives are met and product performance meets customer and quality requirements. Interface with operations, quality, regulatory, clinical affairs, outside consultants and vendors to ensure compliance with internal and external policies and procedures. Accurately and thoroughly document work in support of ISO 13485, GMP requirements and all necessary documentation for planned FDA filings. Presents status of projects and performance data and provides strategic recommendations to company leadership.

  

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 medical device compliance testing, including the 60601 series of standards. 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.