Software Quality Engineer

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

Software Quality Engineer

Warsaw, IN

Hybrid role (3 days in office)

$55 - $64 per hour

ABOUT THE ROLE

Join a Fortune 50 Life Sciences company as a Software Quality Engineer, providing quality leadership for a new product project team focused on the development of medical device software systems. In this hybrid role based in Warsaw, IN, you will serve as the subject matter expert in requirements gathering, software risk assessments, test strategy definition, and guiding the team on design controls and defect analysis. You will partner closely with R&D throughout the full development lifecycle—from upstream requirements and risk through mid-stream verification to ongoing compliance and audit readiness. This is a high-visibility opportunity to own quality end-to-end, gain exposure to a full medical device software toolchain, and collaborate cross-functionally with business partners and mentors.

WHAT YOU'LL DO

• Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products
• Provide leadership, guidance, and expertise on software development processes, procedures, and practices
• Serve as a subject matter expert in requirements gathering, test strategy definition, and design controls
• Facilitate documentation and tracking of verification activities, including code review findings
• Review test case execution results and manage software defects
• Facilitate software risk assessment sessions and own the development of risk documentation
• Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation
• Provide technical support for audits of software suppliers and consultants, including cybersecurity and threat modeling topics
• Conduct training on medical device software development processes and quality systems; develop associated work instructions
• Provide expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
• Collaborate closely with R&D and cross-functional teams to ensure compliance with industry standards and regulatory requirements

WHAT YOU BRING

• Bachelor's degree or university degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering (required)
• Minimum 4 years of regulated industry experience in quality, new product development, or manufacturing engineering
• Experience in the medical device industry
• Proficiency with quality tools, systems, and processes (e.g., Windchill, Polarion, ETQ)
• Strong interpersonal, organizational, and verbal/written communication skills
• Ability to work collaboratively in a team environment and demonstrate leadership
• Ability to perform duties in accordance with company policies, procedures, and civil rights requirements
• ASQ Certification as a Software Quality Engineer or equivalent (preferred)
• Expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
• Experience supporting regulatory filings and registrations (e.g., 510(k) submissions, DHF creation)
• Ability to facilitate software risk assessments and develop risk documentation

WHAT'S IN IT FOR YOU

• Opportunity to own quality end-to-end on a high-visibility project for a Fortune 50 Life Sciences company
• Exposure to a full medical device software toolchain (Windchill, Polarion, ETQ) and hands-on involvement
• Meaningful mentorship scope and cross-collaborative team and business partners
• Hybrid work environment (3 days in office)