Research & Development Scientist
Summary
Develop and validate medical diagnostic products in a regulated lab, translating customer needs into compliant engineering specs while managing design controls and risk processes.
Lead StratifiCare’s pipeline product development effort in compliance with regulatory mandates and internal quality system requirements, which include but are not limited to the following:
- Review and translate customer requirements into engineering specifications (product requirements);
- Lead, drive and ensure that design control activities comply with established procedures;
- Develop and maintain design and development plans;
- Lead device and packaging development efforts, including but not limited to prototyping, feasibility testing, and other engineering studies to evaluate design conforms to specifications;
- Participate in the company’s risk management process;
- Review and approve device design and process changes throughout the medical device lifecycle;
- Collaborate with other functional teams in development of test methods, design verification, manufacturing process, design validation (animal studies, clinical evaluations), and design transfer activities; and
- Maintain safety and operations within the laboratory.
Qualifications:
- PhD or MSc in Immunology or Life Sciences. Experience or knowledge in Oncology and handling clinical samples is a plus.
- Experienced in flow cytometry, ELISA, cell culture, and aseptic techniques.
- Excellent interpersonal skills; ability to build productive working relationships.
- Comfortable working in a highly collaborative and constantly evolving environment.
- Good in problem solving and troubleshooting skills.
- Satisfies the eligibility criteria of the Helix Immersion Programme.
- Experience in flow cytometry product development under ISO13485 setting is highly preferred.
Only shortlisted candidates with the relevant legal right to work in Singapore will be contacted.