Development Quality Engineer II (Medical Device)

This is a fantastic opportunity to launch the next step
in your career with this full-time,
direct hire Development Quality Engineer II role.

This role is with a
global company that has been around for more than 30 years. They invented 3D
printing, brought it into the manufacturing industry, and are experts in five
different kinds of 3D printing that services the medical,
aerospace and defense industries.

In this role, you will be a part of the development
team for the medical device division and will be managing product and process
validation to adhere to industry standards through the design phase of project
life cycles.

This position offers a full benefit package, a front row
seat to cutting edge technology, and opportunities for growth and development.

Development Quality Engineer II Responsibilities:

• Manage customer relationship in the design phase
  of projects to establish and maintain quality standards for the medical device
  industry
• Conduct risk analysis assessments and address
  potential risks throughout the product life cycle
• Ensure compliance with medical device control regulations
• Support internal and external audits, ensuring
  all documentation and processes are compliant

Development Quality Engineer II Requirements:

• Bachelor’s degree in engineering, preferably
  mechanical, aerospace or related field
• 3-5 years of quality engineering experience
  within the medical device industry
• Experience with product and process validations
  with medical device control regulations (FDA 21, CFR Part 820, ISO 13485, ISO 14971, EU MDR)
• Experience with risk management (FMEA, CAPA,
  Statistical Analysis, etc.)

Compensation:

• $75,000- $95,000/year
• Eligible for annual bonus based on company
  performance

Benefits:

• Medical, Dental, Vision
• Life, Critical illness, Accident, Long and
  Short-Term Disability Insurance
• 401(k) Retirement Plan with Employer Match
• Unlimited PTO
• 9 paid holidays

Schedule:

• Monday
  – Friday, 8-5

Location: Littleton, CO

Application is expected to close on September 27th,
2024. Applicant volume and hiring needs may result in early closure or
extension beyond the listed deadline.

If you are interested in this Development Quality Engineer
II opportunity, apply now and please attach your resume for review.

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