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Product Development Engineer

2 weeks ago

Singapore GOODTECH PTE. LTD. Full time

**Job Summary**:
**Key Responsibilities**:

- Collaborate with AI module improvement and validation.
- Collaborate with cross-functional teams, including clinical, regulatory, quality, and marketing, implementing product requirements and specifications.
- Ensure software design complies with relevant medical device regulations and standards (e.g., IEC 62304, ISO 13485, HSA guidelines).
- Work closely with regulatory affairs to ensure software products meet all necessary regulatory requirements and obtain required certifications and approvals.
- Prepare and maintain documentation required for regulatory submissions and audits.

**Qualifications**:

- Bachelor’s or master’s degree in computer science, Software Engineering, Biomedical Engineering, or a related field.
- Minimum of 2 years of experience in software development, preferably in the medical device industry.
- Experience with regulatory compliance for medical devices
- Familiarity with software validation and verification processes.
- Excellent problem-solving skills and attention to detail.
- Strong communication and teamwork abilities.