Medical Device Software Design Quality Engineer

Philips; Bedford (MA); On-site; USD 102,480 - 163,968; Full time

Job summary

A global technology company in Bedford, MA is seeking a Software Design Quality Engineer responsible for developing and managing software quality documentation, ensuring accuracy and compliance throughout the software lifecycle. The ideal candidate will have over 5 years of experience in FDA regulated environments, a strong background in risk management and software validation, and excellent communication skills. This position requires working onsite and may involve occasional travel.

Qualifications

• 5+ years’ experience in FDA regulated, IEC 62304 medical device software.
• Strong understanding of Software Design Assurance and Controls.
• Proven experience with complex medical systems and design quality tools.

Responsibilities

• Leads assessment of software designs and quality standards.
• Conducts root cause analyses for software quality issues.
• Implements software quality plans and regulatory compliance.

Skills

FDA regulated experience

Risk Management (ISO 14971)

Root Cause Analysis

Software V&V

Agile and SAFe methodologies

C/C++/C# programming

Communication skills

Education

Bachelor’s Degree in Quality, Computer Science/Engineering or similar

Job description

A global technology company in Bedford, MA is seeking a Software Design Quality Engineer responsible for developing and managing software quality documentation, ensuring accuracy and compliance throughout the software lifecycle. The ideal candidate will have over 5 years of experience in FDA regulated environments, a strong background in risk management and software validation, and excellent communication skills. This position requires working onsite and may involve occasional travel.