Design Quality Engineer

We are seeking a Design Quality Engineer with strong Medical Device Software / SaMD experience to provide quality oversight for new product development. This role will partner closely with R&D teams throughout software design, development, verification, risk management, and regulatory compliance activities., * Provide Design Quality oversight for Medical Device Software and SaMD products.

• Support software requirements, architecture/design reviews, and design controls.
• Facilitate software risk assessments and maintain risk documentation.
• Review verification activities, test results, code reviews, and software defects.
• Support CAPA, non-conformances, root cause investigations, audits, and regulatory submissions.
• Ensure compliance with IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11, FDA requirements, and EU MDR

• 3 5+ years of Medical Device experience.
• Design Quality Engineering.
• SaMD / Medical Device Software.
• Software Design Controls.
• Software Risk Management.
• Verification & Validation.
• IEC 62304, ISO 13485 and ISO 14971.
• Bachelor’s degree.

Preferred: ASQ Software Quality Engineer certification.

Eligible employees may have access to benefits offered by Intellectt Inc., including medical, dental, vision, and other benefits, subject to eligibility requirements and applicable plan terms. Intellectt Inc. is an Equal Opportunity Employer. We consider qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by applicable law. Thanks & Regards, Soundarya Technical Recruiter Intellectt Inc Direct: Desk number:

Intellectt