Job Description

Immediate need for a talented Software Systems Engineer (exp in Medical device) . This is a 09+ Months Contract opportunity with long-term potential and is located in Pleasanton, CA (Onsite) . Please review the job description below and contact me ASAP if you are interested.

Job ID:-26-09305

Pay Range: $65 - $67/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Serve as a Software Systems Engineer Individual Contributor and Team Lead to deliver:
• Requirements Elicitation
• Requirements decomposition/traceability
• dFMEAs
• SysML/SW Architecture
• Creating Development Plans
• Trade-Off Studies
• Trace Matrix
• Lead technical software design reviews for deliverables
• Own and author of internal design documentation with high level of polish for consumption by other engineers and business partners
• Validate the efficacy and value of implemented design patterns and documentation and continuously improve
• Self-directed coordination of implementation projects, tasks, device documentation and cross training of coworkers
• Responsible for staying abreast of emerging developments in infrastructure and software technologies and making recommendations as appropriate
• Med device exp. required.
• Potential to extend for right candidate but no guarantee. Start asap if onboarding requirements met. Prefer local candidates over others.

Key Requirements and Technology Experience:

• Must have skills : software requirements development, SysML/SW Architecture, FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304
• Years Experience: 5+ years of systems engineering experience
• Skills:-Significant experience in software requirements development
• Ability to work in a geographically diverse environment
• Ability to work within a team and as an individual contributor/team lead in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Ability to maintain regular and predictable attendance
• Experience working in an Agile lifecycle methodology
• Experience as a Software Systems Engineer in a Medical Device company
• Experience requirements management tool
• Experience with FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304
• Education: Bachelor's degree required

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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