Manager, Electrical Engineering

Outset Medical - San Jose, CA

- Manager

San Jose, CA

Miscellaneous Manufacturing

About the position

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.

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.

Requirements

• BS. 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.

Nice-to-haves

• 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.