Senior Manager, Advanced Systems Engineering
On-siteSunnyvale, California, United States
Job Summary
Lead technical development for a portfolio of advanced energy products, owning operational objectives, work plans, and budgets for multiple concurrent development efforts. Establish architecture strategy, set HW/SW requirements, and govern system-level risks while driving cross-functional teams from benchtop to bedside. Direct hardware and software engineering teams on verification methods, oversee regulatory quality processes, and generate technical reports for agency submissions. Represent the portfolio to senior leadership on program health, resourcing trade-offs, and key milestones to influence organizational decisions. Select, develop, and retain talent to build the next generation of technical leaders while advancing advanced energy systems for novel clinical applications across robotic surgical platforms.
Required Qualifications
- Minimum BS required in a relevant engineering discipline
- Minimum 10 years of development experience in a regulated environment
- 3-5 years of people management
- Experience leading multiple teams or programs concurrently
- Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer to manufacturing
- Experience with FDA QSR 21 CFR Part 820
- Experience with ISO 13485
- Experience with ISO 14971
- Experience with IEC 60601
- Experience with IEC 62304
- Experience with analog and digital embedded system and switching power supply design
- Strong understanding of component selection
- Strong understanding of design for reliability and manufacturability
- Strong understanding of the software/firmware development process
- Demonstrated knowledge of electrical component manufacturing processes
- PCB design
- rapid prototyping
- Hardware development experience on energy-based surgical or therapeutic products
- Proven experience using electronic bench equipment such as oscilloscopes and function generators for the bring up and troubleshooting of hardware
- Working knowledge of peripherals commonly used on embedded systems such as ADCs, DACs, PWM and waveform generation and serial communications (UART, I2C, SPI, RS232)
- Contribute to design documentation for test protocols, results and reports and complete tracing for requirements
- Deep hands-on engineering experience with the technical breadth to act as a credible sounding board and reviewer for the team across multiple energy-delivery architectures
- Proven ability to work well in a cross-disciplinary team environment
- Demonstrated program/portfolio management experience including planning and controlling scope, resources, schedule, budget, and deliverables
- Strong business acumen and organizational awareness
- able to implement strategic policies and connect technical decisions to business objectives
- Excellent communication skills
- interpersonal/team effectiveness
- Strong influence-management skills
- Must be available to work full-time
- commute/relocate to Sunnyvale, CA
- Up to 10% travel
- Some international travel may be required
- show current proof of vaccination against certain diseases including COVID-19
Desired Qualifications
- advanced degree strongly preferred (EE preferred)
- MS/PhD or MBA a plus
- advanced degree may offset requisite years
- experience leading multiple teams or programs concurrently strongly preferred (advanced degree may offset requisite years)
- Demonstrated knowledge of electrical component manufacturing processes, PCB design, and rapid prototyping a strong plus
- Hardware development experience on energy-based surgical or therapeutic products preferred
- Entrepreneurial experience a plus
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