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Test Engineer

2 months ago

Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

Job Summary:

Cpl Life Sciences is seeking a skilled Test Engineer to join our team on a 12-month contract basis. As a Test Engineer, you will play a crucial role in determining the performance factors of drug delivery devices and working closely with multidisciplinary teams to ensure compliance with regulatory standards.

Key Responsibilities:

  • Work as part of a multidisciplinary team to identify performance factors of drug delivery devices requiring assessment and investigation.
  • Support interactions with external vendors and internal partners in design verification, shelf life studies, shipping studies, and manufacturing process qualification.
  • Assist in the preparation of regulatory submissions, internal and external audits.
  • Apply statistical, scientific, and engineering expertise to solve problems creatively and independently, supporting decision-making.
  • Develop and validate test methods for the qualification and use of bespoke test equipment.
  • Analyze data using analytical and statistical tools to quantify functional performance characteristics of drug delivery devices.
  • Define approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
  • Perform other duties as assigned to support business goals, including hands-on testing.

Requirements:

Essential Attributes:

  • Degree, HND, or equivalent in a relevant science or bioengineering subject.
  • Previous experience working with device design control systems, life cycle, and drug delivery device testing.
  • Working experience in test method development and validation.
  • Good knowledge of mechanical and/or electronic testing of drug delivery devices.
  • Experience working in teams in the development or troubleshooting of drug delivery devices, analytical methodology, or manufacturing processes.

Desirable Attributes:

  • Evidence of sustained level of achievement.
  • Good theoretical knowledge and understanding of academic subjects.
  • Deep knowledge and application of standards such as Guidance, Design Controls, ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149, and ISTA 2 series, GMP/GLP.

Technical Ability:

  • Good standard of written and spoken English and numeracy.
  • Previous experience within the drug delivery medical device or Pharmaceutical industry.
  • Logical and intuitive thinker.
  • Able to communicate with others outside the team/group.
  • Able to learn and apply established procedures in a reliable and consistent manner.
  • Evidence of productivity, speed, and quality.

Circumstances:

  • Able to travel or relocate to the Cambridge area.
  • Flexible attitude to working hours if the job demands this from time to time.
  • Positive attitude to animal experimentation.