Device Engineer

Overview

On Site
Full Time

Skills

Root Cause Analysis
Continuous Improvement
Regulatory Compliance
Mechanical Engineering
Evaluation
FMEA
Process Control
ROOT
Collaboration
Manufacturing
ISO 9000
Testing
Statistics
Management
Medical Devices
Attention To Detail
Organizational Skills

Job Details

Responsibilities:
  • Conduct experimental testing to support failure investigations and root cause analysis.
  • Develop and execute test procedures to evaluate device performance and functionality.
  • Analyze test data and apply statistical tools to derive actionable insights.
  • Lead testing efforts for design changes and validate proposed modifications.
  • Support scale-up, global launch, and continuous improvement of drug delivery devices.
  • Collaborate with contract manufacturers and suppliers to ensure device quality and compliance.
  • Maintain robust design history files for mechanical and electro-mechanical devices.
  • Enhance Client's delivery device platform to meet evolving product and regulatory requirements.
  • Plan and conduct work requiring independent evaluation and adaptation of techniques.
  • Generate and maintain design specifications, protocols, and reports.
  • Execute design verification/validation, FMEA, and statistical process controls.
  • Perform system-level root cause investigations and coordinate design improvements.
  • Ensure technical records are maintained in design history files.
  • Collaborate with internal teams and external partners to develop manufacturing specifications.
  • Stay current with regulatory standards, including 21CFR820 and ISO 14971.
Requirements:
  • Strong experience in laboratory testing, particularly with combination products or medical devices.
  • Proficiency in statistical analysis and experimental methods.
  • Proven ability to solve problems, implement design solutions, and manage projects.
  • Familiarity with regulatory requirements for medical devices.
  • Exceptional attention to detail and organizational skills.
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