- Develop and maintain embedded and application-level software for medical devices in compliance with FDA ISO 13485 and other regulatory standards.
- Design and implement user interfaces using modern UI frameworks (e.g. React Angular Qt) while adhering to UI design guidelines.
- Perform system-level integration to ensure seamless communication between hardware firmware and software components.
- Conduct comprehensive software testing and validation including unit integration and system testing as well as static and dynamic analysis.
- Write and maintain Software Design Descriptions (SDDs) test procedures and validation reports aligned with medical device documentation standards.
- Build and package installable software (.spk or similar) and work comfortably with Linux development environments.
- Utilize programming skills in Tcl/Tk C Java and/or Python to support new and legacy codebases.
- Handle file system I/O tasks such as USB CD and local directory access.
- Maintain and support legacy systems including tool migration and codebase refactoring.
- Assist in the interpretation review and execution of detailed software and system requirements.
- Collaborate cross-functionally with hardware QA regulatory and clinical teams to ensure compliant and high-quality product development.
- Participate in Agile or Waterfall lifecycle activities including sprint planning backlog grooming requirement tracing code reviews and iterative releases.
- Familiarity with tools like AppMan and software development best practices in regulated industries.
Qualifications :
- 7-10 years relevant work experience.
- Bachelors degree in systems engineering or software engineering required.
- Strong analytical and problem-solving abilities.
- Excellent communication and documentation skills.
- Comfortable working cross-functionally with engineering QA regulatory and clinical teams.
- Ability to interpret and execute complex requirements with attention to detail.
- Knowledge of cloud technologies such as AWS/GCP or Azure.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time