Software Quality Engineer

Software Quality Engineer

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.

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

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

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)