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.
#J-18808-Ljbffr
