Agile Test Developer

5 days ago

Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time
Test Engineer Opportunity

Clinical Professionals Limited is seeking a skilled Test Engineer to join their team on a 12-month contract basis. The successful candidate will work as part of a multidisciplinary team to determine performance factors of drug delivery devices.

Key Responsibilities:
  1. Collaborate with the team to assess and investigate drug delivery devices.
  2. Support interactions with external vendors and internal partners in design verification, shelf life studies, shipping studies, and manufacturing process qualification.
  3. Assist in the preparation of regulatory submissions and internal/external audits.
  4. Apply statistical, scientific, and engineering expertise to solve problems creatively and support decision-making.
  5. Develop and validate test methods for bespoke test equipment.
  6. Analyze data to quantify functional performance characteristics of drug delivery devices.
  7. Define approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
  8. Perform other duties as assigned to support business goals.
Requirements:
  • Degree, HND, or equivalent in a relevant Science or Bioengineering subject.
  • Previous experience of working with device design control system life cycle and drug delivery device testing.
  • Working experience of test method development and validation.
  • Good knowledge of mechanical and/or electronic testing of drug delivery devices.
  • Experience in teams in the development or troubleshooting of drug delivery devices, analytical methodology, or manufacturing processes.
  • Good standard of written and spoken English and numeracy.
  • Previous experience within drug delivery medical device or Pharmaceutical industry.
  • Logical and intuitive thinker with the ability to communicate effectively.
  • Evidence of productivity, speed, and quality.
Desirable Attributes:
  • Evidence of sustained achievement.
  • Good theoretical knowledge and understanding of academic subjects.
  • Preferred deep knowledge of relevant standards (ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149, and ISTA 2 series, GMP/GLP).
  • Literature searching and distillation of findings.
Circumstances:
  • Able to travel or relocate to the Cambridge area.
  • Flexible attitude to working hours if required.
  • Positive attitude to animal experimentation.

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