Device Development Specialist

2 months ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

**Job Description:** Device Development Specialist

Location: Cambridge

Clinical Professionals Limited is a leading provider of pharmaceutical and medical device development services. We are currently seeking a highly skilled Device Development Specialist to join our team in Cambridge.

About the Role:

  • This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in Cambridge, UK.
  • The incumbent will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle.

Responsibilities:

  • Generate and review design history file and risk management file components whilst interacting with cross-functional development teams at all levels of the organisation.
  • Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.

Requirements:

  • BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
  • OR MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
  • OR PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline)
  • History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
  • Understand Good Manufacturing Practices (GMP)


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