Sr. Systems Engineer

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Anshul Bawankar at email address   can be reached on #

630-576-1940

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We have Contract role Sr. Systems Engineer for our client at Pleasanton, CA. Please let me know if you or any of your friends would be interested in this position.
 
Position Details:
Sr. Systems Engineer- Pleasanton, CA
Location                         : Pleasanton, CA
Project Duration        : 7+ Months of contract
Pay Rate                          : $61.29/hr on W2
 
Position Overview
We are seeking an experienced Sr. Systems Engineer to serve as both an Individual Contributor and Team Lead in a fast-paced medical device environment. This role involves end-to-end ownership of system requirements, architecture, and design processes, ensuring compliance with regulatory standards and delivering high-quality engineering solutions.

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Key Responsibilities

• Lead and contribute to requirements elicitation, decomposition, and traceability
• Develop and maintain:
  • System architecture
  • Traceability matrices
  • Development plans
  • Trade-off analyses
  • Design Failure Mode and Effects Analyses (dFMEAs)
• Own and author high-quality design documentation for cross-functional stakeholders
• Conduct and lead technical software design reviews
• Validate design patterns and continuously improve engineering practices
• Coordinate implementation activities, including:
  • Project execution
  • Task tracking
  • Documentation
  • Cross-training of team members
• Collaborate effectively across geographically distributed teams
• Stay current with emerging technologies and recommend improvements

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Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field
• 5+ years of systems engineering experience
• Proven experience as a Software Systems Engineer in a medical device company
• Strong experience in:
  • Software requirements development
  • Requirements management tools
  • Agile development methodologies
• Working knowledge of regulatory standards:
  • FDA 21 CFR 820
  • EU MDR
  • ISO 13485
  • ISO 14971
  • IEC 62304

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Core Competencies

• Strong verbal and written communication skills across all organizational levels
• Ability to work independently and lead teams in a dynamic environment
• Effective multitasking, prioritization, and deadline management
• Demonstrated ability to influence and collaborate with cross-functional teams
• Reliable attendance and strong professional accountability

 
Screening Questions:

• Can you briefly walk me through your experience as a Software Systems Engineer, especially in the medical device domain?
• How many years of hands-on experience do you have with systems engineering activities (requirements, architecture, validation)?
• Have you worked in a regulated environment? Which standards have you directly worked with?
• What type of medical devices have you worked on?

 
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Anshul Bawankar at email address   can be reached on #

630-576-1940

.
 
About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.