MedTech Software Quality Engineer - Hybrid (Warsaw)

Eightelevengroup; Warsaw (IN); Hybrid; USD 76,000 - 88,000; Full time

Benefits offered by this job

Hybrid work arrangement

Mentorship

Exposure to SaMD toolchain

High-visibility project

Job summary

Eightelevengroup in Warsaw, IN is seeking a Software Quality Engineer to lead quality efforts for medical device software. This hybrid role involves shaping requirements, risk assessments, and test strategies across the full development life cycle, with a focus on compliance and DHF/510(k) readiness.

You will collaborate with R&D and cross-functional teams to ensure adherence to IEC 62304, FDA guidance, ISO 13485, and other standards while mentoring team members and driving robust design

Qualifications

• Bachelor's degree in a relevant field required.
• Minimum 4 years in regulated quality, new product development, or manufacturing engineering.
• Experience in the medical device industry is required.
• Proficiency with quality tools, systems, and processes (Windchill, Polarion, ETQ).
• ASQ Software Quality Engineer certification is preferred.

Responsibilities

• Provide quality leadership for software development of SaMD products.
• Lead requirements gathering, risk assessment, and test strategy definition.
• Guide design controls and defect analysis across the project lifecycle.
• Facilitate verification activities and review test results.
• Support regulatory filings and registrations, including 510(k) submissions.
• Assist audits of software suppliers and cybersecurity topics.
• Develop risk documentation and lead risk assessment sessions.
• Provide training and develop work instructions for quality systems.

Skills

Leadership

Communication

Teamwork

Collaboration

Education

Bachelor's degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering

ASQ Certification as Software Quality Engineer (preferred)

Tools

Windchill

Polarion

ETQ

Job description

Eightelevengroup in Warsaw, IN is seeking a Software Quality Engineer to lead quality efforts for medical device software. This hybrid role involves shaping requirements, risk assessments, and test strategies across the full development life cycle, with a focus on compliance and DHF/510(k) readiness.

You will collaborate with R&D and cross-functional teams to ensure adherence to IEC 62304, FDA guidance, ISO 13485, and other standards while mentoring team members and driving robust design