Device Development Scientist

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom SRG Full time
Job Title: Device Development Scientist

SRG is seeking a highly skilled Device Development Scientist to join their team in Cambridge. As a key member of the multidisciplinary team, you will work closely with design, mechanical, quality, compliance regulatory, human factors, and formulation engineers and scientists to develop and test drug delivery devices.

Key Responsibilities:

  • Collaborate with cross-functional teams to determine performance factors of drug delivery devices requiring assessment and investigation.
  • Support interactions with external vendors and internal partners for design verification, shelf life studies, shipping studies, and manufacturing process qualification.
  • Assist in preparing regulatory submissions and internal/external audits.
  • Apply statistical, scientific, and engineering expertise to solve problems creatively and independently, supporting decision-making.
  • Develop and validate bespoke test equipment using method development and method validation principles.
  • Analyse 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.

Basic Qualifications:

  • Degree in a relevant science or bioengineering subject.
  • Previous experience in the medical device or pharmaceutical industry.
  • Experience with device control system life cycle and device testing.
  • Background in analytical method development, design verification, specification setting, and stability testing for drug delivery devices.
  • Good standard of written and spoken English and numeracy.

Desirable Qualifications:

  • Familiarity with medical device or pharmaceutical industry regulations and standards.
  • Experience with guidance, design controls, ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149, and ISTA 2 series, GMP/GLP.

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