Systems Engineer - Designer IV

Description:

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

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:

bull Assures that appropriate resources personnel tools etc. are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

bull 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.

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.

Mentoring

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

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of personnel so classified.

Skills:

Bluetooth Low Energy, BLE, Systems Engineering

Additional Skills & Qualifications:

Bluetooth Low Energy

BLE

Systems Engineering

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.