Embedded Software Engineer for Medical Devices

You will be closely involved with the engineering and documentation of a combination product that combines a medical device with an active drug ingredient and with cloud software. We are pioneering the creation of data-generating medication systems, and more information on our product goals can be found at www.medicasafe.com

Our goal is to achieve FDA submission of our first combination product during early 2022 and receive FDA approval later in the year. The ideal candidate would be able to partner with our current software lead to accelerate software documentation, development and verification tasks. You will work with a cross-functional team of engineers, designers, researchers, and healthcare professionals to help carry our products through to commercialization.

Responsibilities:

• Review existing requirements, design diagrams and firmware code to gain a firm grasp the system's structure
• Author software documentation related to the medical device portion of regulatory submissions (e.g. 510(k), 505(b)(2))
• Contribute to firmware development as needed, potentially including peripheral drivers, application code, integration code, test code, etc
• Coordinate with external resources, suppliers, and field application engineers when required
• Work synergistically with other engineers to optimize the team’s capabilities, processes, and expertise

Key Qualifications:

• Significant experience developing and documenting software for medical devices within design controls
• Experience with FDA 510(k) and/or 505(b)(2) submissions
• Exceptionally strong written and verbal communication skills
• BS, MS or equivalent experience in electrical engineering, computer engineering, or a related field
• Familiarity with software design patterns as they are applicable to development of embedded systems
• General knowledge of modern software development practices such as test-driven development and Agile Kanban
• Ability to read schematics and datasheets

Nice to Haves:

• High level of familiarity with ISO 13485, ISO 14971, 21 CFR 820, IEC 60601
• Experience with cellular communication and IoT devices
• Experience with Autodesk EAGLE or Altium or a similar tool
• Extensive cybersecurity knowledge and/or experience