Systems Engineer (Embedded Development, Firmware Development, BLE, Regulations & Compliance Testing, Risk Analysis, Risk Management, Medical Devices) in Andover, MA

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Job description

Systems Engineer (Embedded Development, Firmware Development, BLE, Regulations & Compliance Testing, Risk Analysis, Risk Management, Medical Devices) in Andover, MA
POSITION: Systems Engineer (Embedded Development, Firmware Development, BLE, regulations & compliance testing, Risk Analysis, Risk Management, Medical Devices)
LOCATION: Andover, MA
SALARY: Excellent Compensation with benefits + 401K
DURATION: Full-Time onsite position
VISA: H1B Transfer candidates will be considered.
SKILLS: Embedded Development, Electrical & Firmware Hardware Development, Design Principles, Wireless Communication, BLE (Bluetooth Low Energy), Medical Devices, System Integration, regulated medical environment, systems development, external contract design, manufacturing facilities, regulations and compliance testing, Risk Analysis, Risk Management

DESCRIPTION:

For one our global clients, we are aggressively searching FOR:

"Systems Engineer with experience in Embedded Development, Firmware Development, BLE, regulations & compliance testing, Risk Analysis, Risk Management, and Medical Devices to be based in Andover, MA"
As a Senior Systems Engineer, you will work with a multi-functional team to develop and sustain technologies and corresponding systems. The candidate will function within a group that acts as the hub of product development within the R&D organization defining the direction of performance requirements, interfaces, subsystem trade-offs and traceability of design control requirements.

This role involves utilizing technical knowledge and engineering tools and methodologies to define and connect pieces across different functional elements (Software, Mechanical, Electrical, etc.) within a regulated environment. You will ensure the product requirements are defined/maintained and the lower-level functional design teams deliver to those requirements. The successful candidate will have a great opportunity to contribute to R&D organization tied to the development of a new business platform.

KEY RESPONSIBILITIES:

• Define and drive system-level requirements and architectural decisions
• Communicate with users, scientists, and customer-facing associates like marketing and field service associates to finesse the customer experience
• Develop system and subsystem requirements. Play an essential role in Risk Analysis and Risk Management.
• Develop and execute formal and informal test protocols. Use finding to drive decision-making and iterate on the design
• Utilize modeling tools to simulate and analyze systems, subsystems and data.
• Communicate requirements and results with the cross-functional teams
• Provide technical expertise to the Systems Engineering Team and cross-functional project teams to support development and submission objectives
• Contribute to best-in-class systems engineering functional excellence, including data-driven approach with focus on superior user experience
• Participate in Design and Technical Reviews to ensure sound decision making is made across the program
• Establish criteria and methodologies for verification and validation of all product requirements.
• Write protocols and reports for integrated system verification and validation testing.
• Support the commercial launch of the system including product surveillance and support.
• Work with process improvement groups to establish effective work products and processes for Systems
• Engineering deliverables and standardize these across all new product development efforts.
• Promote the Systems engineering function and serve as a driver for the application of a systems-oriented focus to all development teams and partners.

As required, serve as a resource within the R&D organization to:

• Analyze, critique and make technical contributions to projects across the breadth of the organization.
• Supply critical organizational, analysis and problem solving skills to all aspects of our development programs.
• Coordinate and handle complex technical development activities involving cross-functional teams working within and external to the organization.
• Serve as a continued customer advocate.

REQUIRED:

• Strong problem-solving and troubleshooting skills.
• Must be a self-starter.
• Strong technical leadership and interpersonal communication skills.
• Excellent oral, written, and presentation skills.
• Ability to work effectively in cross-functional teams.

EDUCATION and EXPERIENCE:

• Minimum of a Bachelor's degree in an engineering field, e.g. System Engineering, Mechatronics Engineering, Electrical Engineering, Software Engineering, Computer Science, Biomedical Engineering, or a closely related technical degree is required.
• Master's Degree in any of the above fields desired.
• 6+ years of hands-on experience in embedded system development.
• Experience in one or more areas related to wireless communication (BLE), medical devices, system integration is required.
• Experience with electrical & firmware hardware development and design principles is required.
• Experience in a regulated medical environment is preferred.
• 10+ years of experience in systems development preferred.
• Familiar working with external contract design and manufacturing facilities.
• Familiarity with regulations and compliance testing is desired.
• Demonstrated experience in working on projects at different stages from concept through commercial launch is preferred.

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