System Engineer - BLE - US Tech Solutions, Inc.

Purpose Statement
The Sr. / Principal Engineer will have experience in BLE Telemetry System Engineer to join our dynamic team in the medical device industry. As a BLE Telemetry System Designer, you will play a crucial role in the development and design of Bluetooth Low Energy (BLE) telemetry systems used in medical devices. You will work closely with cross-functional teams, including engineers, product managers, and regulatory experts, to ensure the successful implementation and integration of BLE technology into our innovative medical devices.
 
Key Responsibilities:

• Design and develop Bluetooth Low Energy (BLE) telemetry systems for medical devices, ensuring compliance with industry standards, regulations, and best practices.
• Collaborate with hardware and firmware engineers to define system requirements and develop specifications for BLE-based communication protocols.
• Conduct feasibility studies and evaluate different hardware and software solutions to identify the most suitable options for BLE integration.
• Create detailed system architecture and design documentation, including block diagrams, flowcharts, and interface specifications.
• Develop and implement algorithms and protocols for data transmission, synchronization, and error handling within the BLE telemetry system.
• Perform system-level testing and verification, including integration testing and troubleshooting of hardware and software components.
• Collaborate with external vendors and suppliers to source and evaluate BLE modules, sensors, and other components required for the telemetry system.
• 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.
• Assist in the preparation and submission of regulatory documentation related to the BLE telemetry system design.
• 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 client Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

 
Experience Requirements:

• Bachelor's degree in electrical engineering, computer science, or a related field. A master's degree is preferred.
• Proven experience in designing and developing BLE telemetry systems for medical devices or a related industry.
• Strong knowledge of Bluetooth Low Energy (BLE) protocols, standards, and profiles.
• Proficiency in software development using programming languages such as C, C++, or Python.
• Familiarity with wireless communication technologies and protocols (e.g., Wi-Fi, Zigbee, NFC).
• Understanding of medical device regulations and standards, such as ISO 13485 and FDA guidelines.
• Demonstrated ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
• 5+ years of experience required. Understanding system requirements.

 
Knowledge

• Experience with wireless medical device requirement connectivity and interoperability standards, such as IEEE 11073.
• Applies a full understanding of BLE/Telemetry to resolve a wide range of issues in creative ways.
• Familiarity with data encryption and security protocols for BLE communication in medical devices.
• Knowledge of embedded systems and real-time operating systems (RTOS).
• Experience with software development tools and methodologies, such as Agile or Scrum.
• Familiarity with medical device risk management processes, including hClientard 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.

 
Discretion/Latitude; Supervision Received; Decision Making

• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

 
Business Relationships and Project Management

• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.

 
Impact

• Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

 
Liaison

• Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

 
MentoringParticipates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.