Responsibilities
- Perform laboratory work (includes handling of biological samples)
- Documentation of product development activities (e.g. product evaluation, artwork documentation, supplier evaluation, risk management) which are in compliance with ISO13485
- Analyze results and communicate with team members during scheduled meetings
- Support product training or event activities.
Requirements
- Bachelor’s degree in Biomedical Sciences, Bioengineering or equivalent
- Knowledgeable and experience in handling immunoassay (e.g. ELISA and lateral flow) and clinical chemistry
- Knowledgeable in product development standards (e.g. CLSI, ISO 14971, IEC 62366)
- Preferably 1 to 2 years working experience in a laboratory
- Prior experience working in an ISO13485 environment and familiarity with medical device design and development will be an advantage
- Able to work independently and in a cross functional team
- Able to communicate effectively
- Comfortable with writing up documents in English
- Well-organized with good documentation habits
- Proactive, responsible, results driven, highly motivated, adaptable and a self-learner
