Senior Validation Specialist for Medical Devices

1 tydzień temu


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

We are looking for a highly skilled Senior Validation Specialist to join our team at Antal Sp. z o.o.

About the Role

This is a challenging opportunity for a talented individual to lead the validation process of medical devices, ensuring compliance with regulatory requirements and industry standards.

Responsibilities

  • Develop and execute system integration and verification plans for new medical diagnostic devices and their subsystems
  • Create just-in-time test protocols to support a traceable continuous integration design methodology
  • Lead test execution throughout the development effort across the medical diagnostic device and its subsystems
  • Report test outcomes with traceable objective evidence to support unbiased technical and project decisions
  • Ensure objective evidence traceability throughout the entire product development lifecycle
  • Champion the adoption and execution of a Shift left strategy through System Design Integration/Verification process improvements and state-of-the-art best practices
  • Leverage a global talent pool to optimize project testing activities quality, cost & duration based on Design Modules reuse
  • Provide technical leadership and knowledge of engineering principles and their application to developing cost-effective, reliable, and high-quality test methods that include elements of microfluidics, optics, thermal transfer, nucleic acid amplification, and robotics

Requirements

  • Education: BS in Engineering, MS in Engineering
  • 10+ years' experience in the engineering/development of complex integrated systems comprised of electromechanical, fluidics and/or assay/chemistry subsystems
  • 5+ years' experience with hands-on laboratory testing execution covering a large variety of 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) & standards and risk management (ISO14971)
  • Ability to interact professionally with all organizational levels, 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 for scripting or data science application

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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