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Senior Systems Engineer
Ref No.: 18-00226
Location: Burlington, Massachusetts
Position Type:Right to Hire
Start Date: 01/03/2018

The Senior Systems Engineer provides systems engineering expertise to new product introductions of electromechanical, software-controlled medical devices.  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 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 the company's product development team to bring systems from concept to launch.
  • Works with marketing and/or product management to develop design input requirements from user and business needs.
    • Leads 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.
    • Experience in developing Risk Management activities.  Experience with ISO 14971 is a plus.
    • Negotiates resolution of problem areas with marketing/product management and the other members of the team.
    • Coaches other team members in methods for developing good product definitions.
  • Recommends the 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
    • Generates the systems integration plan and report.
    • Coordinates 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
Minimum Qualification
  • Bachelor's degree in Engineering and/or Science with 7+ years of experience in developing highly engineered products (at least 5 years in medical/diagnostics products), or an equivalent combination of education and experience (MS with 8 years, or PhD with 5 years).
  • Possesses 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 (at least 3 years) in a highly regulated industry
Additional Qualifications:
  • Conveys very complex information in both written and oral form to a broad audience.
  • Displays an ability to work with a diverse group of people across multiple functions and geographic locations
  • Exhibits strong organization and analytical skills with the ability to multitask.
  • Demonstrates attention to detail and accuracy
  • Influences others, gains acceptance and builds consensus.
  • Is highly motivated, hardworking, well organized, timely
  • Has successfully helped develop and launch multiple medical device/diagnostics products (product enhancements/support is a minimum).
  • Has knowledge of cardiovascular physiology.