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Key Responsibilities
1. Design and develop Bluetooth Low Energy (BLE) telemetry systems for medical devices, ensuring compliance with industry standards, regulations, and best practices.
2. Collaborate with hardware and firmware engineers to define system requirements and develop specifications for BLE-based communication protocols.
3. Conduct feasibility studies and evaluate different hardware and software solutions to identify the most suitable options for BLE integration.
4. Create detailed system architecture and design documentation, including block diagrams, flowcharts, and interface specifications.
5. Develop and implement algorithms and protocols for data transmission, synchronization, and error handling within the BLE telemetry system.
6. Perform system-level testing and verification, including integration testing and troubleshooting of hardware and software components.
7. Collaborate with external vendors and suppliers to source and evaluate BLE modules, sensors, and other components required for the telemetry system.
8. Stay up-to-date with the latest advancements and trends in BLE technology and medical device regulations to ensure compliance and identify opportunities for improvement.
9. Assist in the preparation and submission of regulatory documentation related to the BLE telemetry system design.
10. Collaborate with cross-functional teams to ensure seamless integration of the BLE telemetry system into the overall medical device design.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
* Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
* Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Experience Requirements
1. Bachelor's degree in electrical engineering, computer science, or a related field. A master's degree is preferred.
2. Proven experience in designing and developing BLE telemetry systems for medical devices or a related industry.
3. Strong knowledge of Bluetooth Low Energy (BLE) protocols, standards, and profiles.
4. Proficiency in software development using programming languages such as C, C++, or Python.
5. Familiarity with wireless communication technologies and protocols (e.g., Wi-Fi, Zigbee, NFC).
6. Understanding of medical device regulations and standards, such as ISO 13485 and FDA guidelines.
7. Demonstrated ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
8. 5+ years of experience required. Understanding system requirements.
Knowledge
1. Experience with wireless medical device requirement connectivity and interoperability standards, such as IEEE 11073.
2. Applies a full understanding of BLE/Telemetry to resolve a wide range of issues in creative ways.
3. Familiarity with data encryption and security protocols for BLE communication in medical devices.
4. Knowledge of embedded systems and real-time operating systems (RTOS).
5. Experience with software development tools and methodologies, such as Agile or Scrum.
6. Familiarity with medical device risk management processes, including hazard analysis and mitigations.
Problem Solving
- Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
Planning and Organization
- Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
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About Advantage TechnicalWith company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .
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