Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Pleasanton, CA for a Sr. Systems Engineer role to assist their team. This is an on-site role.
Industry: Medical device
Title: Sr. Systems Engineer
Pay rate: $60/hr on W2
Location: Pleasanton, CA
Duration: 12 months contract with possible extension or hiring
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Job Description:
The Systems Engineer (Contract) will be accountable for delivering systems engineering tasks for significant portions of Sustaining programs including integration of mobile systems, wireless technologies into medical devices. Working in Pleasanton, CA, the primary responsibilities include systems integration, formal verification, following design change control process, including supporting in-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
• Plans, manages, and reports on overall systems integration.
o Generates / Supports the systems integration plan and report.
o Coordinates system engineering testing to verify systems functionality including software.
o Drives and records configuration of system at integration points.
o Supports system design change control process.
o Leads / Executes system verification execution.
o Identifies and escalates risks in terms on systems viability with existing requirements.
o Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
o Ensures tracing from requirements to test. Working experience with Requirements Managements tools e.g., DOORS, JIRA etc.; use and administration of DOORS a plus.
o Experience in understanding medical device standards (62304, 60601, etc.) a plus
• May support Internal and External Audits, as directed by management.
• 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
Required
• Bachelor’s degree in engineering and/or Science with 1+ year of experience in developing highly engineered products (at least 1 year 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 in a highly regulated industry
• Excellent verbal and written communication skills, with ability to communicate effectively to Core Team.
• Previous experience working in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.