Design Verification Specialist

Role Summary / Purpose:

We’re looking for an experienced and multi-disciplinary Design Verification Specialist to join our Design Verification team.  In this role, you will be a key member of the R&D team providing expertise and support to ensure the successful delivery of R&D projects.  You will be responsible for the planning and execution of design verification activities, including verifying the performance of NDI products, driving technical issues to resolution, and communicating across the broader organization.

Scope of Responsibilities:

  • Collaborate with Project managers and R&D teams to define, develop and maintain design verification test Protocols throughout the product development life cycle
  • Execution and verification of the performance and technical specifications of NDI systems, including firmware, hardware, application software and manufacturing process
  • Report test results in accordance with the verification and traceability requirements of the NDI product development and quality processes
  • Manage product defects and technical issues, driving them to resolution with the appropriate project manager(s) and R&D technical functions
  • Develop tools (software and hardware) to support design verification activities
  • Participate in and collaborate with internal and external stakeholders on product validation activities
  • Research new technologies implemented in NDI products to ensure complete and efficient test plan coverage
  • Participate in product design and risk management reviews throughout the product development life cycle
  • Participate in technical requirement and design reviews across multiple R&D disciplines

Quality Requirements:

NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices and employees of NDI.  Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold.  Employees of NDI are instrumental to our compliance efforts and are required to understand and comply with the QMS.

This role has accountability for ensuring projects are executed in accordance with the verification and traceability requirements incorporated in ISO 13485 and outlined in NDI product development processes

Education and Professional Qualifications:

  • Post-secondary degree or diploma in Engineering, Computer Science or an equivalent related field
  • 5+ years of experience with complex technical product verification, in a product development environment

Required Skills:

  • Experience in electronics and software design and development
  • Strong foundation in a range of engineering disciplines (Software, Mechanical and/or Electrical)
  • Demonstrated experience and capabilities in the following:
    • Design verification test protocol development based on product requirements and specifications
    • Testing and reporting of results for products running embedded software and software applications
    • Management of product defects and technical issues
    • Development of tools and infrastructure for testing
  • Excellent problem-solving skills, able to trouble shoot and bring up incomplete or new hardware / software during early exploratory verification test cycles
  • Able to work with and resolve ambiguity and conflicting needs
  • Above-average interpersonal, verbal and written communication skills
  • Team player:  Ability to work collaboratively; able to influence and drive to positive resolution identified product defects during the design and verification cycle
  • Sense of urgency:  Able to work to and maintain schedules and deadlines during new product introduction
  • Programming experience in Python test environments

Desired Characteristics/Additional Assets:

  • Experience with medical device standards and quality systems (i.e.  13485) for new product development (or other highly regulated product development environments)
  • Understanding of traceability requirements for medical device development
  • Exposure to, and understanding of, project management basics and core-team based product development
  • Programming experience in Java and C++ environments