R&d Software Design Control Specialist - Medical Devices

Agilent Technologies UK

Glostrup, Denmark
Not specified; not specified; compyny pension sche...
Fully remote
Experience with design control activities
Knowledge of medical device regulatory requirements
Ability to convert user needs to product requirements
This role involves driving software lifecycle engineering activities to ensure efficient progress in new and sustaining projects for pathology staining instruments

Job Summary

  • This role involves driving software lifecycle engineering activities to ensure efficient progress in new and sustaining projects for pathology staining instruments.
  • The specialist is responsible for executing design control activities, ensuring compliance with regulatory requirements, and contributing to the product Design History File.
  • Agilent offers a dynamic working environment with career development opportunities, a company pension scheme, and private health care benefits.

Matching Summary

This role involves driving software lifecycle engineering activities to ensure efficient progress in new and sustaining projects for pathology staining instruments.

Salary

Not specified; Not specified; Company pension scheme, individual bonus plan, private health care, medical & life insurance

Skills & Requirements

Must-have

  • Experience with design control activities
  • Knowledge of medical device regulatory requirements
  • Ability to convert user needs to product requirements
  • Conduct software and cybersecurity risk assessment
  • Collaborate with cross-functional stakeholders

Nice-to-have

  • Experience with Agile software development
  • Knowledge of IEC 62304 and ISO 14971 standards
  • Background in Life Science fields
  • Strong communication and coordination skills
  • Systematic approach to complex documentation

Key Requirements

  • Engineering university degree in IT/Computer/Software or Life Science
  • Experience in regulated environments such as Medical Devices or Pharma
  • Excellent English verbal and written communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter