Immediate need for a talented R&D Systems Engineer (Medical Devices). This is a 06+months contract opportunity and is located in San Diego, CA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 26-11336
Pay Range: $50/hr - $60/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision).
Note; Seeking a systems Engineer contractor for a new product development project, with potential for extension or conversion to full-time. The role focuses on requirements management, verification/validation, and traceability within the medical device R&D framework, requiring 4 days/week on-site in San Diego.
Key Responsibilities:
- Cross-functional coordination across R&D, quality, regulatory, marketing, and manufacturing to translate stakeholder needs into system/product requirements
- Requirements must follow the V-diagram methodology: Inputs (user needs, regs, hazards) → product requirements → product specifications → Build → verification of specifications → verification of Requirements → Design validation
- Ensure complete traceability from user needs through requirements, specifications, to verification/validation for FDA audit readiness
- Lead hazard identification and mitigation (e.g., pinch points, tip-over risks)
- Write design verification protocols and reports proving design outputs meet design inputs
- Conduct design validation to confirm the right product was built to meet actual user needs
- Lead feasibility and risk assessments for new product direction decisions
- Facilitate cross-functional problem resolution when requirements aren't met or reliability issues arise
- Drive continuous process improvements and apply DFSS (Design for Six Sigma) best practices
- Create system architecture documentation including block diagrams and system integration plans.
Key Requirements and Technology Experience:
- Bachelor's degree in science/engineering (biomedical, mechanical, or electrical engineering most common); Master's/PhD preferred
- Minimum 5 years as a systems engineer in medical device, aerospace, or defense industries
- Requirements management tools: DOORS, TFS, JIRA, JAMA, Confluence, Polarian, or Cockpit
- Strong requirements traceability experience (not just requirements writing)
- Systems integration and testing expertise (must be well-rounded, not testing-only)
- System architecture planning and design capabilities
- DFSS methodology (design of experiments, root cause analysis, fishbone diagrams)
- Reliability engineering knowledge to collaborate with in-house reliability engineers
- AI experience for process efficiency improvements in requirements writing, traceability, and hazard management
- Ability to communicate technical details to engineers and business concepts to executives
- Strong writing skills for audit-ready documentation
- Extreme attention to detail (every "I dotted, T crossed" for FDA audits)
- Critical Distinctions
Our client is a leading Medical Device 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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