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Tier-1 employer, metro location, mid-level/staff title and broad software requirements increase candidate competition.
Medical-device software and regulatory experience are highly industry-specific, reducing cross-industry transferability.
Explicit 4+ years plus regulatory, documentation, and medical-device compliance skills make screening stringent.
Design and develop advanced software components and systems for medical devices, ensuring compliance with regulatory standards and quality management systems.
Lead problem solving and design tradeoff decisions at the component and sub-system level to meet user needs and clinical requirements.
Collaborate across R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing teams to support product development from concept through launch while generating and reviewing necessary engineering documentation.
Bachelor's degree in Software Engineering, Computer Science, or related discipline.
Minimum 4 years of relevant work experience in software development.
Strong understanding of Software Development Life Cycle processes and medical device regulatory and compliance standards.
Not explicitly mentioned in the JD: notice period or specific location requirements.
Experienced in designing and developing embedded or application software for medical devices with demonstrable knowledge of design principles, coding standards, and testing methods.
Capable of independently balancing design trade-offs and executing problem-solving in complex, regulated environments involving cross-functional collaboration.
Familiar with tools for static/dynamic code analysis, memory management, code coverage, and Application Lifecycle Management/Traceability in software projects.