Senior Manager, Advanced Systems Engineering

Job description

Job responsibilities

• Own the operational objectives, work plans, staffing, and budgets for multiple concurrent advanced-energy development efforts (capital equipment), delegating execution across cross-functional teams and shared service…
• Establish and assure adherence to budgets, schedules, resource plans, and top-level deliverables across a portfolio of parallel programs at differing stages of maturity, each built on a distinct energy-delivery…
• Direct HW/SW requirements generation and modelling across programs (requirement writing, translation, decomposition, management systems, tracing, HOQ/QFD); set the methods and standards the broader team follows
• Oversee system-level technical risk registers across programs, including burn-down strategy and risk tracing, and drive cross-program mitigation decisions
• Govern system architecture, boundary diagrams, and use conditions across the portfolio, and oversee test-method development, execution, and master/top-level verification plans
• Set direction for hardware and software engineering teams on the best methods to satisfy and verify design requirements, ensuring design outputs are successfully integrated into effective system designs across programs
• Support the quality and regulatory processes as required
• Represent the portfolio to senior and executive leadership including technical progress, development health, program risks and mitigations, resourcing trade-offs, and key milestones in order to influence senior…

Job requirements

• Minimum BS required in a relevant engineering discipline; advanced degree strongly preferred (EE preferred), MS/PhD or MBA a plus
• Minimum 10 years of development experience in a regulated environment, minimum 3 years of people management; experience leading multiple teams or programs concurrently strongly preferred (advanced degree may offset…
• 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, ISO 13485, ISO 14971, IEC 60601, IEC 62304 and other related external standards Experience with analog and digital embedded system and switching power supply design
• Strong understanding of component selection, and design for reliability and manufacturability
• Strong understanding of the software/firmware development process
• 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