Summary: As a Software Engineer specializing in medical devices, you will play a crucial role in designing, developing, and maintaining software that is integral to our medical device products. You will work closely with cross-functional teams, including hardware engineers, clinical specialists, and regulatory experts, to deliver software solutions that meet rigorous standards for safety, performance, and usability.

Key Responsibilities:

Develop detailed work plans, schedules, project estimates, resource plans, and status reports. Monitor and troubleshoot performance and schedule issues.
Support the project team throughout the software development life cycle, including execution of deliverables for regulatory submissions of software applications.
Develop, oversee, review, and execute software test plans and test procedures; execute software verification and validation tests.
Partner with the Global Cybersecurity Office to coordinate threat identification/remediation, product assessments, and execute cybersecurity solutions for products.
Collaborate with cross-functional and cross-divisional experts in a wide range of fields to solve complex engineering and business challenges.
Translate highly technical results into easily understood recommendations that will influence senior stakeholders.
Coordinate walkthroughs and reviews; ensure conformance to standards and adherence to design controls.
Manage third-party designers, vendors, and contractors to deliver high-quality engineering solutions at an accelerated pace.

Requirements:

Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
Minimum of 7 years of experience with software engineering in the medical device industry required.
Familiarity with medical device software standards and regulations (e.g., FDA, ISO 13485, IEC 62304).
Software development lifecycle experience is required.
Proficiency in programming languages such as C, C++, Python, or Java.
Experience with embedded systems and real-time operating systems (RTOS).
Experience developing software test plans, test procedures, and executing software verification and validation tests.
Cybersecurity experience preferred.
Strong communication and cross-functional collaboration skills to influence across functions.

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Enhanced Compliance Inc.

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