Job Title - Device Development Scientist
Location – Cambridge
Contract - 12 months
Pay - £19.49 - £24.94 per hour
SRG are working with a global leading pharmaceutical company that are seeking a Device Development Scientist to join their busy team. The job requires close working with multidisciplinary teams comprising Design, Mechanical, Quality, Compliance Regulatory, Human Factors and formulation Engineers and Scientists, who are working on drug delivery device development / testing.
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