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Device Development Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom SRG Full time

Job Overview

SRG is seeking a highly skilled Device Development Specialist to join our team. As a key member of our multidisciplinary team, you will play a crucial role in the development and testing of 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 in design verification, shelf life studies, shipping studies, and manufacturing process qualification.
  • Assist in the preparation of regulatory submissions and internal/external audits.
  • Apply statistical, scientific, and engineering expertise to solve problems creatively and independently, supporting decision-making.
  • Develop and validate 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:

  • 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.