Medical Device Development Scientist

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

Cpl Life Sciences is seeking a highly skilled Medical Device Development Scientist to join our team in Cambridge. As a key member of our multidisciplinary team, you will be responsible for determining the performance factors of drug delivery devices and working closely with design, mechanical, quality, compliance regulatory, human factors, and formulation engineers and scientists.

Key Responsibilities:

  • Work with a multidisciplinary team to assess and investigate performance factors of drug delivery devices.
  • Support interactions with external vendors and internal partners in design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices.
  • Assist in the preparation of regulatory submissions and internal and external audits.
  • Apply statistical, scientific, and engineering expertise to solve problems creatively and independently and support decision-making.
  • Apply method development and method validation principles to the qualification and use of bespoke test equipment.
  • Analyse data using analytical and statistical tools to quantify the functional performance characteristics of drug delivery devices.
  • Define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.

Requirements:

  • Degree, HND, or equivalent in a relevant science or bioengineering subject.
  • Previous experience of working with device design control systems, 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 of working in teams in the development or troubleshooting of drug delivery devices, analytical methodology, or manufacturing processes.

Desirable Attributes:

  • In-depth statistical data analysis skills.
  • 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.

Presentations:

  • Able to anticipate what information is required by colleagues and disseminate it actively and efficiently.

Motivation:

  • Enjoys working within multidisciplinary teams in the development of leading-edge designs and technologies.

Personal Characteristics:

  • Takes pride in the quality of their work.
  • Effective team worker.
  • Able to plan, organise, and prioritise own work.
  • Comfortable working to agreed deadlines.
  • Able to work with limited supervision.
  • Willing to listen and take advice from others.
  • Has good communication skills.
  • Good attention to detail.

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.

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