Senior Medical Device Complaint Handling Engineer

TechDigital Group

Alameda (CA)

On-site

USD 80,000 - 120,000

Full time

14 days+

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Job summary

An established industry player is seeking a Regulatory Affairs Specialist with extensive experience in medical devices. This pivotal role involves overseeing complaint handling processes, ensuring compliance with regulatory standards, and actively participating in the development of quality systems. The ideal candidate will have a strong background in regulatory experience and complaint handling, along with excellent problem-solving and communication skills. Join a dynamic team dedicated to maintaining high standards of quality and compliance, where your contributions will directly impact the success of critical product lines in the medical device sector.

Qualifications

  • 8 to 12 years of experience in Regulatory for Medical Devices.
  • 4 to 6 years of experience in Complaint Handling.

Responsibilities

  • Implement and maintain the effectiveness of the quality system.
  • Evaluate complaints against criteria for reportable events.

Skills

Regulatory experience
Complaint Handling
Problem-solving skills
Communication skills

Job description

DevOps Engineer with Agentic AI experience
Core must-haves (screen for these explicitly)
  • Applied Agentic AI engineering experience: evidence of building Agentic workflows - ideally delivered into a real project.
  • Modern multi-agent architecture experience: hands-on designing/implementing systems where multiple AI Agents collaborate.
  • Strong understanding of agentic frameworks/tools: candidates must be able to name the frameworks used, explain why chosen, and describe components.
  • Protocols knowledge with practical relevance: working knowledge (preferably applied) of MCP, A2A, ACP—and ability to explain how they're used in real-world AI Agent systems.
  • Architecture & design contribution capability: candidate should be able to contribute to solution architecture, discuss trade-offs/pros-cons, and guide design decisions for agentic systems.
  • Strong proficiency in devops practices and tools.
  • Proficient in python programming language.
  • Experience with kubernetes and containerization technologies.
  • Knowledge of ci/cd pipelines and automation tools.
  • Ability to lead and motivate a technical team effectively.
  • Excellent problem-solving and communication skills.
  • Strong analytical and decision-making abilities.
Certifications: Relevant certifications in DevOps, python, or Kubernetes are a plus.
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Medical insurance
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401(k)