Endotronix - Naperville, IL

posted 3 days ago

Full-time - Senior
Naperville, IL
Miscellaneous Manufacturing

About the position

The Senior Software Test Engineer at Endotronix will play a crucial role in developing and enhancing software processes for manufacturing and testing within the medical device sector. This position focuses on scalability and efficiency, requiring expertise in software development, validation, and project management. The engineer will lead process development activities, design custom software solutions, and ensure compliance with industry standards, all while collaborating with various stakeholders to improve product quality and operational efficiency.

Responsibilities

  • Develop current processes with a focus on scalability in software for manufacturing and testing.
  • Lead and support process development activities to increase throughput and ease of manufacture.
  • Design and develop LabVIEW custom software or similar for manufacturing and testing purposes.
  • Develop and maintain software requirement documentation.
  • Develop and maintain software validation plan and protocols.
  • Lead and execute software validation testing for process validation.
  • Coordinate projects and manage timelines effectively.
  • Work closely with internal and external customers and vendors to resolve issues and provide technical support.
  • Lead and direct meetings with team members and hourly associates.
  • Manage manufacturing software within repositories.
  • Provide training and guidance to other employee levels in the operation and testing of software.
  • Develop and participate in process tracking metrics to drive process improvements.
  • Interact with vendors and suppliers to ensure timely completion of deliverables.
  • Perform additional related actions and duties as outlined by management.

Requirements

  • 5-7 years of experience as a Software Development or Software Test Engineer or similar role.
  • Experience with developing manufacturing or test software.
  • Strong proficiency with LabVIEW and MATLAB.
  • Experience with Python is preferable.
  • Experience with developing software requirements and validation.
  • Medical device software validation experience, ISO13485 preferable.
  • Medical device manufacturing GMP quality experience preferable.
  • Experience with unit testing.
  • Strong project management skills.
  • Demonstrated ability to work independently with minimal supervision.
  • Excellent oral and written communication skills, particularly in technical writing and documentation.
  • Demonstrated organizational, interpersonal, and critical thinking skills.
  • Proficiency with Microsoft Office Suite.

Nice-to-haves

  • Experience in digital healthcare solutions.
  • Familiarity with data-driven decision-making processes.

Benefits

  • Equal employment opportunities without discrimination.
  • Commitment to diversity and inclusion in the workplace.
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