Sr. Software Systems Engineer

Experteer Overview In this role you support software-intensive medical device development by providing design quality oversight across the design control lifecycle. You will collaborate with cross-functional teams to ensure regulatory and quality compliance, with a focus on software and system-level design. This position sits within the Neuromodulation and Pelvic Health Pre-Market Design Quality team, enabling you to impact patient outcomes through robust design, risk management, and verification activities. You will help shape product quality, safety, and compliance in a fast-paced, regulated environment. Compensation / Benefits * Provide design quality support for software-enabled medical device development from concept to manufacturing transfer. * Ensure compliance with design control, software lifecycle, and risk management requirements. * Review and contribute to system and software requirements, architecture, and design documentation. * Develop verification and validation strategies for software, system, and integration testing. * Collaborate with engineering, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues. * Evaluate deliverables for completeness, traceability, and regulatory readiness. * Support risk management activities including hazard analysis and mitigation verification. * Participate in design reviews and provide feedback to improve quality, safety, and compliance. * Assist in root cause analysis and corrective actions for design or software quality issues. * Mentor less experienced engineers on design quality practices and compliance requirements. * Contribute to continuous improvement of design quality processes, tools, and templates. Tasks * Bachelor’s degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or related technical field with 4+ years of relevant experience (or Master’s with 2+ years, or PhD with 0 years). * Experience with design controls, software lifecycle activities, and verification/validation. * Strong understanding of risk management, design failure analysis, and traceability across requirements, design, and testing. * Experience supporting cross-functional product development teams. Key requirements * Health, Dental and Vision insurance * 401(k) plan plus employer contribution and match * Incentive plans * Tuition assistance/reimbursement * Employee Stock Purchase Plan * Paid time off and holidays

with for software, system, and integration testing. * Collaborate with engineering, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues. * Evaluate deliverables for completeness, traceability, and regulatory readiness. * Support risk management activities including hazard analysis and mitigation verification. * Participate in design reviews and provide feedback to improve quality, safety, and compliance. * Assist in root cause analysis and corrective actions for design or software quality issues. * Mentor less experienced engineers on design quality practices and compliance requirements. * Contribute to continuous improvement of design quality processes, tools, and templates. Tasks * Bachelor’s degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or related technical field with 4+ years of relevant experience (or Master’s with 2+ years, or PhD with 0 years). * Experience with design controls, software aaaaaaa

• activities, and verification/validation. * Strong understanding of risk management, design failure analysis, and traceability across requirements, design, and testing. * Experience supporting cross-functional product development teams. Key requirements * Health, Dental and Vision insurance * 401(k) plan plus employer contribution and match * Incentive plans * Tuition assistance/reimbursement * Employee Stock Purchase Plan * Paid time off and holidays