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 109,000 colleagues serve people in more than 160 countries.

We are recruiting for a Systems Engineer II to join our team in Burlington, MA. The Systems Engineer II will be accountable for delivering systems engineering tasks for significant portions of programs with some level of novelty. The primary responsibilities include the elicitation and management of design input requirements from customer and business needs. This individual will also provide critical input to the systems architecture and will own the systems integration and design change control process. The individual will be expected to provide leadership, mentoring, and direction to other team members from a wide range of functions and/or geographical locations. This engineer is a key member of Abbott’s product development team to bring systems from concept to launch.

WHAT YOU'LL DO

• Works with Systems Engineering Leads to develop design input requirements from user and business needs. Participates in the generation of the system design input requirements.

• Ensures tracing between user and business needs, and the design input requirements.  Use and administration of DOORS a plus.

• Makes sure design input requirements include safety risk management requirements, and human factors. Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.

• Collaborates with other team members in methods for developing good product definitions. Negotiates resolution of problem areas with marketing/product management and the other members of the team.

• Participates in recommending system architecture for a set of products indented to perform a protocol or function.

• Models’ systems behavior to drive architectural decisions and requirement definition and refinement.

• Drives the decomposition of design input requirements into detailed subsystem requirements.

• Provides links between design inputs, architectural components, and subsystem requirements, to ensure design meets expectations.

• Develops a documentation tree to support the systems architecture.

• Plans, manages, and reports on overall systems integration, Verification and Validation Activities

  • Generates the systems integration, Verification and Validation plans and reports.

  • Coordinate’s system engineering testing to verify systems functionality.

  • Drives and records configuration of system at integration points.

  • Owns system design change control process.

  • Supports system verification execution

  • Identifies and escalates risks in terms on systems viability with existing requirements.

  • Identifies and escalates issues with operation and use of systems engineering tools

  • Provides recommendations to the management on systems engineering issues

• Fosters collaboration with cross-functional teams, platform architects and other leaders to drive work to completion and resolve issues. Successfully influences stakeholders. Communicates effectively with cross-functional teams and senior management. Keeps leadership informed of progress and issues.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• Cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION & EXPERIENCE YOU'LL BRING

Required

• Bachelor’s degree in Engineering and/or Science

• 2+ years of experience in developing highly engineered products (medical/diagnostics products preferred), or an equivalent combination of education and experience

• Systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).

• Systems engineering experience in a highly regulated industry

Preferred 

• Master’s Degree in Engineering (Computer, Electrical, Computer Systems, or Software), Computer Science, or related discipline

• Medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc.)

• Experience in Human Factor Engineering

• Experience in developing Risk Management activities.  Experience with ISO 14971 is a plus.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

• Training and career development, with onboarding programs for new employees and tuition assistance  

• Financial security through competitive compensation, incentives, and retirement plans  

• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs 

• Paid time off  

• 401(k) retirement savings with a generous company match 

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.