Principal Engineer

Job Description:

Responsibilities:

• 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.
• Plans and organizes non-routine tasks w/approval.
• Initiates or maintains work schedule and priorities.
• Plans and organizes project assignments and maintains project schedules.
• Works under general direction regarding the direction and progress of projects and special assignments.
• Independently determines and develops an 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.
• Establishes and cultivates a wide range of business relationships to facilitate the 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 represent a specialized field in larger project teams.
• Influences middle management on business solutions.
• 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.
• Represents the 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 the manager.
• Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• 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 who 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 Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Experience:

• 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 hazard analysis and mitigations.