Device Development Specialist
5 days ago
Job Title: Device Development Specialist
Role Overview:
We are seeking an experienced Device Development Specialist to join our team at BioTalent. As a key member of our multidisciplinary team, you will be responsible for assessing and investigating performance factors of drug delivery devices.
Main Responsibilities:
- Work with our team to determine key performance indicators for drug delivery devices.
- Support interactions with external vendors and internal partners for design verification, shelf life studies, shipping studies, and manufacturing process qualification.
- Contribute to regulatory submissions and internal/external audits.
- Apply scientific and engineering expertise to solve problems creatively and independently.
- Develop and validate test equipment principles for drug delivery devices.
- Analyse data using analytical and statistical tools to quantify performance characteristics.
- Define approaches to quantify design parameters, including design of experiments and statistical interpretation.
- Perform other duties as assigned to support business goals.
Basic Qualifications:
- Degree in a relevant Science or bioengineering subject.
- Previous experience in the Medical device or Pharmaceutical industry.
- Experience working with device control systems, life cycle, and testing.
- Team experience in development or troubleshooting of drug delivery devices, analytical methodology, or manufacturing processes.
- Demonstrated knowledge in analytical method development, design verification, specification setting, and stability testing.
- Good standard of written and spoken English and numeracy.
Desirable Qualifications:
- Familiarity with Medical device or Pharmaceutical industry standards.
- Work experience with regulatory guidelines, ISO standards, and industry-specific regulations.
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