W2 ONLY!!! NO C2C!!!!!

Position: Sr. Systems Engineer

Location: San Diego, CA

Duration: 5 Months

Responsibilities:

• Collaborate with Systems Engineers, Operations, Quality, Regulatory, design teams to analyze existing product documentation (G7, Stelo) and identify gaps in requirements traceability all the way to manufacturing.
• Develop and maintain comprehensive traceability matrices linking design inputs, design outputs, and manufacturing processes.
• Define and document manufacturing requirements based on design requirements, specifications and performance criteria.
• Participate in design reviews and provide input on manufacturability and testability.
• Support the development of process control plans and inspection procedures.
• Identify and propose solutions to address gaps and inconsistencies in requirements and processes.
• Work with cross-functional teams (design, manufacturing, quality) to ensure alignment on requirements and processes.
• Provide training and guidance to other team members on requirements management and traceability best practices.

Required:

• Proven experience tracing high-level design input requirements to manufacturing process controls.
• Expertise in requirements elicitation, analysis, and management using INCOSE Requirements standards.
• Proficiency with Jama Connect requirements management tools.
• Strong understanding of product development lifecycle, from concept to manufacturing.
• Excellent communication and collaboration skills.

Preferred:

• Experience with statistical analysis and data interpretation
• Experience with CGM technology or other medical device development
• Familiarity with ISO 13485, FDA 21 CFR Part 820 and other relevant regulatory standards

Hardware Skills Required:

• Experience with hardware testing equipment is a plus, specifically related to CGM devices. Understanding of hardware architecture, interface specifications, and system-level design.