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Abbott · 5 months ago

Staff Engineer, Software Design Assurance (Medical Device)

Burlington, MA

Full-time

Onsite

Senior Level, Lead/Staff

$99K/yr - $199K/yr

8+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an experienced Staff Engineer, Software Design Quality to ensure that medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards, providing quality oversight for Software Development projects.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product software

Support software verification and validation activities for new products and software changes in accordance with plans. Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation

Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems

Perform risk assessments and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues

Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met. Represent the Global Design Quality Department for final review and approval of project deliverables

Support non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required

May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team

Work as an individual contributor and provide guidance or oversee work of other Software Quality team members

Support audits and lead quality system improvement activities

Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures

Qualification

Software Design QualityFDA regulations knowledgeISO 13485Software Standards 62304FMEA/risk managementRequirements management toolsMedical device software lifecycleBachelor’s degreeCloud-based networksMobile applicationsProblem reporting systems