Medical Product Software Development Engineer
Biotronik
- Lake Oswego, OR
- Permanent
- Full-time
- Contributing to the development of a patient-facing Android app, a clinician-facing Windows GUI, and embedded software for the Bluetooth-connected therapy device
- Participate in all phases of the software development process, including requirements definition, implementation, and verification
- Collaborate with Product Management, Project Management, System Engineering, Research, and Usability Engineering to improve our SW products
- Generate and maintain relevant software documentation
- Technology selection to meet evolving product requirements and SW platforms
- Other duties may be assigned at the discretion of the manager
- Education / Experience Requirements
- BS Degree in computer science, electrical engineering, or related field
- 2 years of graduate-level coursework and/or experience in software product development
- 2 years of experience using C#
- 2 years of experience with development environments, debugging tools, git, test automation, and defect tracking tools
- 1-year Android app development
- Good understanding of cybersecurity in mobile devices
- Strong written and verbal skills
- Additional Preferred Knowledge, Skills, Abilities:
- Experience with the Xamarin framework
- Bluetooth communication on Android, Windows, or iOS
- C/C++ on SoC-based platforms (ESP32, Nordic nRF52, or similar ARM-based MCUs)
- Salesforce Health Cloud platform
- Knowledge of NoSQL databases (ideally Couchbase)
- Web technologies (REST APIs, JSON)
- Experience with the concepts and development of Software as Medical Device (SaMD) and Mobile Medical Applications (MMA), as defined by FDA.
- Experience with FDA, 21CFR820, ISO 13485, IEC 62304, and regulatory submission of Class III Medical Devices a plus
- This position is remote across the US. We maintain an office in Lake Oswego, Oregon. We expect the engineer to occasionally travel for on-site meetings, and we prefer local candidates