Insulet Corporation

Manager, Systems Design Verification

Job Locations US-MA-Billerica | US-MA-Billerica
Posted Date 3 weeks ago(2/2/2018 12:11 PM)
Category
Engineering / Program Management

Position Summary

The Manager, Systems Design Verification, will support and coordinate Systems Engineering responsibilities related to design verification of Insulet’s products.  This position entails the management and execution of design verification tasks for new product development.

 

The Position will report to the Systems COE Leader, Advanced Technology & Engineering located at Insulet’s Headquarters in Billerica, MA.

Responsibilities

  • Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
  • Work with Systems engineers and members of other product development teams to develop procedures and protocols for system level design verification. Includes obtaining approval from all stakeholders.
  • Manage the verification and validation of products, as well as validation of test tools.
  • Participate in design input definition, design reviews and risk management activities for new product development.
  • Analyze design changes implemented after execution of verification and validation to determine regression testing required.
  • Generate verification and validation timelines and resource needs as input to product development plans.
  • Drive improvements to the design control and risk management processes derived from verification and validation activities.
  • Ensure compliance of products with the pertinent regulations required for electrical medical devices.
  • Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.

Education and Experience

  • A Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required, a Master of Science degree is desired. An alternative technical degree may be acceptable.
  • A minimum of 5 years’ experience managing design verification activities in a multidisciplinary project team environment
  • Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs.
  • Demonstrated expertise in design verification practices such as test method and test case development, protocol and report writing, and product issue tracking
  • Experience working in a medical devices and highly regulated product development environment
  • Excellent management skills; experience and capability managing collaboration under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts

Preferred Qualifications:

  • Demonstrated skills in verifying innovative FDA regulated medical devices (Class 1, 2 or 3) using processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
  • Demonstrated success in managing all design verification activities for projects from development through commercialization

Physical Requirements:

  • Travel overnight(s) as necessary both domestically and internationally to support project goals.

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