Job Summary:
We are seeking a highly skilled and motivated medical device Product Development Engineer to join our dynamic team. The successful candidate will be responsible for the design, development, and maintenance of software products that meet regulatory requirements for medical devices. This role requires a good understanding of both software engineering and medical device regulations, ensuring our products are safe, effective, and compliant.
Key Responsibilities:
· Collaborate with software development team on design, develop, and maintain software applications intended for use as medical devices.
· 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.
