Device Development Scientist
4 weeks ago
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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