Software Gigs

Senior Software QA Engineer supporting Dexcom's Postmarket Investigations team to assess real-world product performance, investigate software and device issues, and drive continuous improvement. You will collaborate across R&D, Quality, Regulatory Affairs, and Clinical teams to conduct root-cause analyses, perform risk assessments (including hazard analysis, DFMEA, PFMEA), and translate postmarket insights into product enhancements. The role requires deep technical understanding of software architecture, structured problem-solving, statistical analysis, and the ability to communicate findings to both technical and non-technical stakeholders while ensuring regulatory compliance and patient safety.

As a Systems Engineer, you will troubleshoot complex mechanical, electrical, and software issues in advanced 3D printing (ECAM) systems, identify root causes, and develop solutions to improve printer fleet performance. You'll analyze manufacturing and quality data to drive continuous improvement, apply structured problem-solving methodologies (8D, 5 Whys, Fishbone), and support corrective and preventive actions (CAPA). You'll partner across mechanical, electrical, and software engineering teams to ensure system integration, develop technical documentation and SOPs, and execute functional test plans. The role requires hands-on troubleshooting of electromechanical systems, knowledge of quality tools and methodologies, and CAD expertise.

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections. The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.

Lead software development for an FDA-cleared blood testing platform, overseeing instrument software, application software, cloud connectivity, cybersecurity, and software quality systems. Manage the full software development lifecycle including requirements, risk management, design controls, verification and validation, and regulatory compliance. Work closely with Quality and Regulatory Affairs on FDA submissions, audits, documentation, and post-market support. Direct strategy, roadmap planning, architecture, and release management for a regulated in vitro diagnostic (IVD) medical device.