Design Quality Engineer – SaMD

My name is Uzma Kousar Mohammed, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Design Quality Engineer SaMD based in Boston, MA with one of our prestigious clients. We are seeking a Design Quality Engineer with strong Medical Device Software / SaMD experience to provide quality oversight for new product development.

Hello,

I hope you're doing well.

My name is Uzma Kousar Mohammed, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Design Quality Engineer SaMD based in Boston, MA with one of our prestigious clients.

I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

uzma.kousar@intellectt.com

Job Title: Design Quality Engineer SaMD
Location: Boston, MA
Client: Hologic / ALKU
Industry: Medical Device / SaMD
Pay Rate: $45 $48/hr

Job Description:

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.

Key Responsibilities:

• 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.

Required Skills:

• 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.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Thanks & Regards,
Uzma Kousar Mohammed
Technical Recruiter
Intellectt Inc

uzma.kousar@intellectt.com

Direct: 732 993 4997
Desk number: 732 412 6999- Ext: 139