Systems Engineer II

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Position Summary:

We are recruiting for a Systems Engineer II to join our team in the Burlington, MA location.  In this role, you will be performing systems engineering activities on new product introductions and supporting existing products in the field for electromechanical, software-controlled medical devices. This includes decomposing proposed and existing requirements, creating and maintaining trace-ability from user needs through test reports, product and component risks, including cyber security. You will also provide input to the systems architecture and own the systems integration and design change control process. 

Primary Responsibilities:

• Works with Systems Engineering leads to identify and develop design input requirements from user and business needs.
• Participates in the generation of the system and component design input requirements.
• Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
• Works with project team to support the decomposition of design input requirements into detailed subsystem requirements.
• Knowledge of standards applicable to Class III medical devices and tracing them to requirements.
• Develops a documentation tree to support the systems architecture.
• Provides links between design inputs, architectural components and subsystem requirements, to ensure design meets expectations.
• Ensure design input requirements are traced to safety risk management requirements, human factors, cyber security risks and applicable country-based standards.
• Creates tracing between user needs and the design input requirements using industry recognized software tools.
• Supports in Verification and Validation testing efforts through design, development and post launch.
• Works with cross functional team to develop cyber security risk assessment
• Participates in cyber security design efforts for product development projects. This includes but is not limited to embedded electronic devices, connected smartphones, and web-based product solutions.
• Participate in cross-team coordination to achieve defined security goals as well as meet technical requirements in support of detailed implementation plans for security projects.
• Create cyber security risk documents that meet regulatory requirements for existing and new products in development.

Required Qualifications:

• Bachelor’s degree in Engineering, Sciences, or related discipline
• 3+ years of experience in a highly regulated industry developing highly engineered products, performing risk management, system integrations, and/or protocol testing
• Demonstrated experience understanding of development life cycle, including revision control, change management and product support
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Preferred Qualifications:

• Advanced level degree(s) in Engineering, Sciences, or related discipline
• Medical device experience
• Working knowledge of statistical analysis and understanding of risk analysis as it applies to cyber security
• Previous Experience with ISO 14971
• Knowledge and programming experience in DOORS

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