Job Description

Our client is a global healthcare company that specializes in medical devices, diagnostics, pharmaceuticals, and nutrition products. The company develops a wide range of products, including glucose monitoring systems, cardiovascular devices, and diagnostic tests.

We are looking for an experienced Staff Software Quality Engineer to ensure our medical devices meet rigorous design control standards and align with the latest industry practices. This role serves as a key technical representative, providing oversight for software development projects and ensuring software quality engineering methodologies are upheld.

• Provide oversight of design control deliverables for software development, including medical product software (cloud-based patient care networks, mobile applications, embedded software), non-medical software, and non-product software.

• Support software verification and validation efforts, including reviewing and approving requirements, software test case protocols/reports, development plans, and system/software documentation.

• Evaluate, prioritize, and develop action plans for addressing software defects reported in problem resolution systems.

• Conduct risk assessments related to software development, including FMEA, product risk analysis, and mitigation of software-related concerns.

• Participate in technical and management reviews to ensure compliance with design plans, product design requirements, and software deliverables.

• Support non-product software validation, assisting with documentation, protocols, and reports as needed.

• Contribute to product cybersecurity assessments as part of a cross-functional team.

• Provide guidance to other Software Quality team members while managing individual responsibilities.

• Support audits and lead efforts to improve quality system processes.

• Ensure compliance with regulatory standards, including FDA regulations, EUMDR, ISO 13485, ISO 14971, and IEC 62304.

• Bachelor's degree or equivalent in a scientific, technical, or engineering discipline.

• At least 8 years of experience in software development and design quality engineering.

• Strong knowledge of medical device software development lifecycle, including cloud-based networks and mobile applications.

• Familiarity with regulatory frameworks such as FDA guidance, ISO 13485, ISO 14971, EU MDR, and MDSAP.

• Experience using requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA).

• Hands-on expertise in FMEA/risk management.

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