Senior Principal Systems Engineer Role
We are seeking a talented and experienced Principal Systems Engineer to join our Surgical Instruments team in Lake Forest, CA. In this role, you will be responsible for developing SysML models, performing system and subsystem architecture and requirements definition, integration, and evaluation of complex medical equipment. This equipment utilizes various technologies, including electronics, firmware, embedded software, computer software, mechanics, optics, and fluidics.
Key Responsibilities:
- Develop SysML models, derive user needs, manage product requirements (including full traceability), manage risks, perform technical planning, conduct design reviews, verify and validate systems, handle project scheduling, and manage budgets.
- Conduct analyses at all levels of the total system product, including concept, design, fabrication, testing, installation, operation, maintenance, and disposal.
Key Requirements/Minimum Qualifications:
- Bachelor's degree or equivalent years of directly related experience
- Fluency in reading, writing, understanding, and communicating in English
- 7 years of relevant experience
Preferred Qualifications/Skills/Experience:
- Experience breaking down customer inputs into user needs and product requirements that define functional architecture
- Experience with requirements management and tracing tools (e.g., Polarion, PTC Integrity, DOORS)
- Experience with systems engineering methods and modeling tools utilizing SysML (e.g., MagicDraw)
- Familiarity with developing custom embedded electrical/software systems
- Comfortable with risk assessment and management processes
- Capable of generating and reviewing substantial amounts of documentation
- Knowledge of IEC 60601-1 family of standards, ISO 14971, and ISO 13485
- Relevant product development and engineering experience (medical experience not required)
- Familiarity with developing complex, integrated, embedded systems
