Sr. Software Test Engineer

Teleflex
Chelmsford, Massachusetts

Position Summary

Teleflex’s Arrow line of intra-aortic balloon catheters and balloon pump consoles are the result of years of clinical and engineering expertise from multiple venues that have come together to bring to market innovative cardiac assist products for critically ill patients who require balloon pump support.

We are looking for a Senior Software Test Engineer to contribute on multiple software projects. This individual will have an exciting opportunity to make important contributions on multiple software and hardware projects within the organization.

Principal Responsibilities

  • Create and execute manual and automated unit tests using python or equivalent programming language to ensure quality and reliability for newly implemented or modified software features.
  • Perform static code analysis, generate reports & participate in technical reviews to ensure well-designed and well-tested code.
  • Perform manual and daily automated builds as needed.
  • Manage V&V documentation, including derivation of Test Procedures from System and Sub-System Specifications, validation of Test Procedures and Test Fixtures, and generation of test reports in support of regulatory fillings for Class II medical devices.
  • Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled.
  • Responsible for timely completion of software test deliverables (including Plans, Protocols and Reports) in compliance with IEC 62304 and Teleflex procedures.
  • Perform preliminary testing on prototype code for newly implemented / modified software features.
  • Investigate issues & anomalies, perform risk and root cause analysis.
  • Support other functions including but not limited to Quality, Regulatory, and Operations with any software related issues.
  • Provide Software technical expertise to investigate NCs, CAPAs and complaints.

Education / Experience Requirements

  • Bachelors degree in Computer Science, Electrical or Electrical & Computer Engineering, or Biomedical Engineering related field & 5 years of hands-on experience in testing embedded software, preferably in medical devices
  • MS in related field and 3 years of hands-on experience in testing embedded software, preferably in medical devices
  • Experience with embedded operating systems, e.g. QNX, Linux and various RTOS’s;
  • Experience in developing test scripts & test-cases using shell scripts or python or any equivalent programming language
  • Experience with software controlled electromechanical products
  • Knowledge of serial and network data communication protocols
  • Familiar with SW development tools, e.g. Git, Jira, VM, Makefile, compilers etc.

Specialized Skills / Other Requirements

  • Familiar with Agile SW development life cycle
  • Knowledge of Test Driven Development approach preferred
  • Self-motivated and able to work independently with minimum supervision
  • Familiar with industrial coding standards for safety and security, e.g. MISRA, CERT-C etc.
  • Knowledge of medical device software development lifecycle and regulatory requirements related to software containing medical devices
  • Excellent verbal & written communication skills
  • Must possess high degree of organizational skills and be a self-starter
  • Ability to work in team environments
  • Ability to plan and prioritize activities
  • Ability to work independently to meet assigned project deadlines

LI-DR1

Hace 9 días