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R&D Engineer II – Medical Device Development

Integer Holdings Corporation · Spiddal

New
🇬🇧 English
Quality Management Systems (QMS) failure analysis

Job description

About the role

The R&D Engineer II will contribute to the design, development, and improvement of medical device products and processes. Working within Integer’s engineering team, you will apply both standard and advanced engineering methods to meet internal and external customer expectations while complying with regulatory and quality standards.

Key responsibilities

  • Apply general and advanced engineering techniques to develop and refine medical device products.
  • Ensure compliance with Quality Management Systems (QMS), FDA regulations, and company safety, environmental, and security policies.
  • Conduct failure analysis on existing products, processes, and materials and recommend improvements.
  • Participate in moderate‑complexity projects, documenting and implementing new product and process technologies.
  • Plan, schedule, and execute engineering tasks within larger projects or lead smaller‑scope initiatives.
  • Review procedures and work instructions prior to implementation and make minor adaptations as needed.

Required profile

  • Bachelor’s degree in Engineering or a related technical field.
  • Experience in the medical device industry or a regulated engineering environment.
  • Ability to work independently with occasional guidance from senior engineers or managers.
  • Strong judgment in applying engineering standards and adapting specifications.

Required skills

  • Quality Management Systems (QMS)
  • FDA regulatory compliance
  • Failure analysis
  • Product development
  • Process development

What we offer

  • Opportunity to work on innovative medical device technologies.
  • Collaborative environment guided by core company values.
  • Professional growth within a global organization.

Questions fréquentes

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Published 23 hours ago

Expires 1 month from now

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Integer Holdings Corporation

Spiddal