Test Engineer for Life Sciences

3 tygodni temu


Warszawa, Mazovia, Polska Antal Sp. z o.o. Pełny etat
Job Description

We are seeking a highly skilled Test Engineer for our client, a global leader in developing and manufacturing life science research and clinical diagnostic products.

About the Job

The successful candidate will be responsible for establishing and executing system design integration/verification plans for medical diagnostic devices and their subsystems. This includes defining test cycles, configuring test articles, prioritizing design requirements, and developing integration/verification strategies.

You will also develop just-in-time test protocols to support continuous integration design methodology, lead test execution throughout development efforts, report test outcomes with traceable objective evidence, and ensure objective evidence traceability throughout the product development lifecycle.

Key Responsibilities
  • Develop and execute system design integration/verification plans for medical diagnostic devices and their subsystems
  • Define test cycles, configure test articles, prioritize design requirements, and develop integration/verification strategies
  • Develop just-in-time test protocols to support continuous integration design methodology
  • Lead test execution throughout development efforts
  • Report test outcomes with traceable objective evidence
  • Ensure objective evidence traceability throughout the product development lifecycle
Requirements
  • Bachelor's degree in Engineering; Master's degree in Engineering preferred
  • 10+ years' experience in engineering/development of complex integrated systems comprising electromechanical, fluidics, and/or assay/chemistry subsystems
  • 5+ years' experience with hands-on laboratory testing execution covering various scientific/engineering tools/equipment, test methods/design of experiment, and outcomes at various stages of product maturity
  • Experience working in a regulated industry, ideally with IVD experience, QSR/ISO regulations (e.g., ISO 13485, IEC 62304), and risk management (ISO14971)
  • Ability to interact professionally with all organizational levels; ability to work and excel within a fast-paced, dynamic, evolving, and changing work environment
  • Familiarity with software development life cycle (SDLC) processes, agile methodologies, and continuous integration/continuous deployment (CI/CD) practices
  • Proficiency with Python or Matlab preferred for scripting or data science applications
What We Offer
  • An attractive, challenging job in an interdisciplinary R&D team
  • Access to a comprehensively equipped lab
  • A great deal of autonomy and opportunities for growth
  • Private medical care
    • Sports card
    • Sharing the costs of professional training & courses
    • Flexible working hours


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