Device Development Scientist

5 hours ago

Cambridgeshire, United Kingdom BioTalent Full time

Job Title: Device Development Scientist

Location: Onsite- Cambridgeshire, England, United Kingdom

Duration: Long-term 12 months rolling

Key responsibilities:

  • Works as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
  • Support interactions with external vendors and internal partners within the following activities: design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices
  • Assist preparation of regulatory submissions, internal and external audits.
  • Apply statistical, scientific and engineering expertise and research experience 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.
  • Uses analytical and statistical tools to analyse the data in order to quantify the functional performance characteristics of the drug delivery device, the controlling parameters for its consistent performance, etc.
  • Able to define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
  • Performs other duties as assigned in support of business goals e.g. hands-on testing.

Basic Qualifications:

  • Degree in in relevant Science or bioengineering subject
  • Previous experience within Medical device or Pharmaceutical industry.
  • Previous experience of working with device control system life cycle and device testing.
  • Experience of working in teams in the development or trouble shooting of drug delivery devices, analytical methodology or manufacturing processes by means of designed experiments and logical problem solving.
  • Demonstrates a knowledge and 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.
  • Previous experience within drug delivery medical device or Pharmaceutical industry.

Desirable Qualifications:

  • Familiar with Medical device or Pharmaceutical industry.
  • work 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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