A medical device manufacturing client is looking for a Software Engineer to join their team. A successful candidate will have advanced software-development expertise and will work as part of a multidisciplinary project team to develop a complete surgical navigation product. This role involves solving complex navigation, positioning, and system-control challenges while contributing to software design, development, testing, documentation, and product improvement.
The ideal candidate has strong C/C# programming experience, a background in developing complete software products, and experience working in a regulated environment, preferably within the medical-device industry.
Key Responsibilities
- Design, develop, test, and maintain software for an electromagnetic positioning and surgical navigation system.
- Develop software solutions to complex navigation, positioning, and system-control problems.
- Contribute to the design and development of complete software products from concept through implementation and testing.
- Collaborate with software, systems, hardware, quality, regulatory, and other functional teams to achieve project objectives.
- Troubleshoot software issues and identify effective technical solutions.
- Participate in software architecture, design reviews, code reviews, and peer reviews.
- Prepare technical reports, specifications, test documentation, and other required project documentation.
- Use software configuration-management and defect-tracking tools in accordance with established procedures.
- Identify and recommend improvements to software development processes, products, and engineering practices.
- Support compliance with applicable company policies, procedures, regulatory requirements, and software-development standards.
- Contribute to innovation and the generation and protection of intellectual property through appropriate development practices and documentation.
- Clearly communicate project status, technical findings, risks, and results to project stakeholders.
Required Qualifications
- Bachelor's or Master's degree in Software Engineering, Computer Science, or a related technical field.
- 5 or more years of professional software-development experience
- Proven experience developing and delivering complete software products.
- Strong programming experience in C, C#, or a comparable programming language.
- Experience with software development, troubleshooting, testing, and technical documentation.
- Experience working with software configuration-management and defect-tracking systems.
- Experience participating in code reviews, peer reviews, and structured software-development processes.
- Strong knowledge of software-development best practices.
- Strong technical writing and documentation skills.
- Strong verbal and written communication skills.
- Demonstrated ability to collaborate effectively with cross-functional and multidisciplinary teams.
- Ability to work within established company procedures and compliance requirements.
- Knowledge of applicable software regulations, standards, and development practices.
Preferred Qualifications
- Experience developing medical-device software.
- Experience working in an FDA- or otherwise regulated development environment.
- Experience with surgical navigation, electromagnetic tracking, positioning systems, robotics, embedded systems, or related technologies.
- Familiarity with software lifecycle processes used in medical-device development.
- Experience working with complex hardware/software systems.
- Experience with navigation, tracking, coordinate systems, or real-time system control.