Staff Software Quality Engineer - Med Devices

ENCHANNEL MEDICAL LTD; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

ENCHANNEL MEDICAL LTD is seeking a Quality Engineer, Staff (Software) in California. This hands-on role focuses on software design controls for capital medical devices, ensuring compliance with FDA and EU regulations. Candidates should have over 5 years of experience in Software Quality Engineering within the medical device field, with a solid understanding of design documentation and regulatory requirements. The position offers the chance to influence the quality culture in a dynamic environment centered on patient care.

Qualifications

• 5+ years of Software Quality Engineering experience within the medical device industry.
• Demonstrated independent experience remediating software design documentation.
• Direct experience supporting software new product development.

Responsibilities

• Lead execution of software design controls remediation.
• Partner with software and R&D to ensure compliance.
• Support FDA inspections and regulatory submissions.

Skills

Software Quality Engineering

Regulatory Compliance

Risk Management

FDA Submissions

ISO Standards

Education

Bachelor’s degree in Engineering or Computer Science

Tools

IEC 62304

IEC 62366

Job description

ENCHANNEL MEDICAL LTD is seeking a Quality Engineer, Staff (Software) in California. This hands-on role focuses on software design controls for capital medical devices, ensuring compliance with FDA and EU regulations. Candidates should have over 5 years of experience in Software Quality Engineering within the medical device field, with a solid understanding of design documentation and regulatory requirements. The position offers the chance to influence the quality culture in a dynamic environment centered on patient care.