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Careers at Lifeware Labs

Feb 1, 2024

Lifeware Labs, LLC is an interdisciplinary company combining expertise in embedded systems, soft robotics, signal processing, and machine learning. We are currently seeking strong applicants to help us lead the development of next generation wearable technologies in healthcare.

We’re proud of our team. We value individuals who have a talent for learning and are easy to work with. When our individuals grow, we grow as a team. As a start-up out of Carnegie Mellon, Lifeware prioritizes individuals who demonstrate curiosity, creativity, passion, and a broad skill set:

  • Highly disciplined and self-driven, yet knows when to reach out for help.

  • Ability to collaborate with a multidisciplinary team of engineers to advance Lifeware’s product pipeline.

  • Contributes ideas and inventions towards R&D and products related to wearable technology for healthcare.

  • Delivers results against aggressive timelines.

The following positions are currently open, however we encourage anyone with interest to apply:

Career1

Embedded Developer

Lifeware Labs is seeking an experienced embedded developer to lead firmware development for our wearable devices. This position will involve microcontroller development using the nrf Connect SDK environment, as well as Arduino development for prototyping purposes. This position will involve significant collaboration with both the electrical engineering and app development teams. The embedded developer will develop unit tests and related documentation. This is a heavy "hands-on" position; the developed firmware will be deployed, tested in clinical trials, and ultimately become FDA cleared.

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Key Responsibilities

  • Develop operating system for Lifeware's wearable devices.

  • Prototype, test, and deploy firmware in a well documented manner.

  • Implement new firmware features that improve both the user experience as well as the overall scalability of deployment.

  • Coordinate with other teams within Lifeware Labs, included the electrical engineering and app developer teams.

Qualifications

  • Bachelors, Masters, or Doctoral Degree in Electrical Engineering, Computer Science, or related field.

  • Preferred: 2+ years experience with nrf Connect SDK

  • Experience with firmware level software programming (C,C++)

  • Experience with driver level development

  • Examples of completed projects using custom PCBs or Arduinos.

  • Excellent independent learner.

Mobile Application Developer

Lifeware Labs is currently seeking candidates to lead development of our iOS and Android mobile applications. You will be involved with all aspects of developing, deploying and maintaining mobile based applications.

 

We are looking for highly motivated developers who are passionate about building software solutions in the wearable electronic medical devices field. Applicable candidates include those with an undergraduate or graduate degree in computer science or related field.

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Key Responsibilities

  • Develop secure and responsive mobile applications for iOS and Android platforms using Swift and Java.

  • Design mobile interfaces to efficiently display data.

  • Design and develop apps that interact with other bluetooth devices.

  • Communicate and present designs and solutions to the Lifeware team

  • Implement good software development practices including documentation, unit tests.

Qualifications

  • Bachelors, Masters, or Doctoral Degree in Computer Science, Electrical and Computer Engineering, Human Computer Interaction, or related field.

  • Experience developing mobile applications on iOS and Android using Swift and Java.

  • Optional: Experience working with BLE communication on both iOS and Android.

  • Optional: Experience with CoreML, CoreData on iOS

  • Optional: Experience with ONNX and Room Database on Android

  • Preferred: 2+ years of work experience working as a mobile application developer

  • Familiarity with software development practices such as agile and/or Kanban

  • Strong problem-solving skills

  • Excellent interpersonal and communication skills

Career2

Regulatory Specialist

Lifeware Labs is seeking a candidate that will help guide the organization through regulatory compliance activities for FDA clearance of our ProPatch wearable device.

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Key Responsibilities

  • Manage, prepare, and submit regulatory submissions required for medical device approvals and registrations in the US in collaboration with the product team. 

  • Correspond and collaborate with an interdisciplinary engineering team.

  • Conduct regulatory evaluation of changes to medical device products in accordance with requirements and generate the required regulatory submission. 

  • Provide expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements. 

  • Support preparation of Instructions For Use (IFU) in collaboration with the team.

  • Perform regulatory research to inform strategy. 

  • Assist personnel to ensure clinical research and clinical evaluation are performed in accordance with regulatory requirements. 

  • Provide regulatory expertise to marketing material.

  • Support preparation of materials, reports and follow-up with Regulatory Agencies regarding recall activity. 

  • Support quality system and technical file/design dossier audits.

Qualifications

  • Bachelors or Masters Degree in science, engineering or a related field.

  • At least 3 years regulatory experience in medical device development (prior regulatory affairs experience in a medical device start-up is preferred).

  • Regulatory submissions development experience.

  • Strong working knowledge of the U.S. FDA medical device regulations and guidances.

  • Strong working knowledge and experience with quality management systems (ISO 13485 and 21 CFR 820).

  • Working knowledge and experience with risk management.

  • Experience with clearing medical devices to market in the US (510(k), De Novo, Class II or III).

  • Strong problem-solving skills.

  • Excellent interpersonal and communication skills.

  • Ability to translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements.

  • Approachable individual who provides a high level of teamwork and interdisciplinary collaboration.

  • Experience in project management and/or people management.

  • Solid understanding of IEC 60601 series standards (preferred).

  • RACS certification is preferred but not required.

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