Demo

Engineer 4 - Design Quality

System One
Denver, CO Other
POSTED ON 10/1/2024 CLOSED ON 1/26/2025

What are the responsibilities and job description for the Engineer 4 - Design Quality position at System One?

Title: Design Quality - Engineer 4
Location: Lakewood, CO - on-site 3 days/week
Type: Direct Hire
Shift/Schedule: M-F 8am – 5pm
Salary: $123,600.00 - $154,500.00 with 10% bonus

Overview:
Our well-established medical device client is seeking a Design Quality Engineer (QE), who will ensure high-quality medical devices by driving design, development, and risk management. You will focus on areas including software, electromechanical devices, and disposable products.

Responsibilities:
  • Collaborate with I&D teams to bring medical devices to market.
  • Evaluate Design and Development deliverables to ensure high-quality products meet customer needs.
  • Support SW development improvements in agile environments while complying with medical device regulations.
  • Anticipate roadblocks and provides direction for navigating the quality system.
  • Ensure thorough root cause analysis for design changes or validation failures.
  • Translate critical design attributes to design outputs.
  • Guide major programs and may take on project leadership roles.
  • Act as the prime technical contact, coordinating with external teams on significant matters.
  • Develop technical specifications and ensures regulatory compliance (FDA).
  • Direct phases of complex engineering work, developing new approaches to problems.
  • Create new processes impacting multiple disciplines.
  • Contribute to business objectives, goals, budgets, and costs.
  • Present complex technical information and responds to inquiries.
  • Mentor junior engineers and provides cross-functional guidance.
  • Consult on broad technical and industry issues.
  • Work on complex issues requiring deep analysis and judgment.
  • Oversee technicians and junior engineers.

Requirements:
  • 8 years of experience, including 3-4 in medical devices (quality for design and development in R&D or quality).
  • Bachelor of Science degree or Master of Science degree in Engineering or computer science preferred
  • Strong in design quality for embedded medical device software or software development for devices.
  • Understanding of software functionality.
  • Experienced in risk management and product development as a development or design quality engineer.
  • Hands-on with test method validations; product knowledge required beyond document review.
  • Familiar with software development and agile methodologies.
  • Knowledge of 21 CFR 820.30, ISO 13485, ISO 14971, and ISO 62304.
  • Skilled in technical innovation and leadership in mechanical/chemical engineering, fluids engineering, and cellular biology.

Salary : $123,600 - $154,500

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