DOORS Systems Engineer (Medical Devices, FDA)

Description:

The Senior Systems Engineer (Contract) will be accountable for supporting the delivery of systems engineering tasks for significant portions of programs including integration of medical device components into a single system that include wired and wireless technologies. Working on-site in Pleasanton, CA, the primary responsibilities include systems integration, formal verification, following design change control process, including supporting on-market products. The individual will be expected to provide hands-on execution and work with other team members from a wide range of functions and/or geographical locations. Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion.

RESPONSIBILITIES

• Executes system engineering testing to verify systems functionality including software and system components.
  • Drives and records configuration of system at integration points.
  • Supports system design change control process.
  • Supports systems integration / verification plan and report.
  • Generates Systems test protocols, reports.
  • Executes system verification testing.
  • Identifies and escalates risks / system anomalies with existing requirements.
  • Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
  • Ensures tracing from requirements and risk to test protocols and reports.
    • Working experience with Requirements Managements tools e.g., DOORS, JIRA, etc.
  • Experience in understanding medical device standards (62304, 60601, etc.) a plus.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Anticipated business travel around 10%.

EDUCATION AND EXPERIENCE YOU LL BRING

Required

• Bachelor s degree in engineering and/or Science with 5+ years of experience in developing highly engineered products (at least 3 years in medical/diagnostics products), or an equivalent combination of education and experience.
• Possesses systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).
• Systems engineering experience (at least 3 years) in a highly regulated industry.

• Excellent verbal and written communication skills, with ability to communicate effectively with Core Team members.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Preferred

• Master s degree in engineering (Computer, Electrical, Computer Systems, or Software), Computer Science, or related discipline.
• Medical device experience, specifically supporting heart failure and/or cardiovascular systems.

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