System Design Validation Engineer @ Antal Sp. z.o.o. in Antal Sp.z.o.o.

For our Client, global leader in developing and manufacturing a wide range of products for the life science research and clinical diagnostic markets, we are looking for candidates for the position of:

System Design Validation Engineer

Your duties & responsibilities:

• establish, maintain, and execute on the system design Integration/Verification plan for a new
  medical diagnostic device and its subsystems (Test Cycles definition, Test Articles configurations,
  Design Requirements prioritization, Integration/Verification strategies)
• develop just in time test protocols to support a traceable continuous integration design
  methodology (Test Method library, Sample Size determination, Risk Management mitigations)
• lead test execution throughout the entire development effort across the medical diagnostic
  device and its subsystems (test Personnel capability & capacity, test Equipment development &
  qualification, test Vendors partnerships)
• report test outcome with traceable objective evidence to support unbiased technical and
  project decisions (Defects report, Statistical significance, Technical/Design reviews, Regulatory
  Agency/Notified Bodies submissions)
• ensure objective evidence traceability throughout the entire product development lifecycle
  (Raw data & records retention, Quick access to multiple layers of information, Design History
  File)
• champion the adoption and execution of a Shift left strategy through System Design
  Integration/Verification process improvements and state-of-the-art best practices (Design for Six
  Sigma, Continuous Integration tools, LEAN management, Design Control)
• leverage a global talent pool (France, Switzerland, USA) 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
• eventually be able to lead a systems Integration/Verification team and implement functional 
  management processes and tools to monitor progress of engineering deliverables across the 
  portfolio

What employer offers:

• an attractive, challenging job in an interdisciplinary R&D teams
• access to a comprehensively equipeed lab
• a great deal of autonomy and opportunities to growth
• private medical care
• sports card
• sharing the costs of professional training & courses
• flexible working hours

Employer

• 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. Ideally in the life sciences / diagnostics industry or equivalent experience in other industries. Should have full product development cycle experience with demonstrated commercial success of the product in the field
• 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 stage 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. 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 application

For our Client, global leader in developing and manufacturing a wide range of products for the life science research and clinical diagnostic markets, we are looking for candidates for the position of:

System Design Validation Engineer

Your duties & responsibilities:

• establish, maintain, and execute on the system design Integration/Verification plan for a new
  medical diagnostic device and its subsystems (Test Cycles definition, Test Articles configurations,
  Design Requirements prioritization, Integration/Verification strategies)
• develop just in time test protocols to support a traceable continuous integration design
  methodology (Test Method library, Sample Size determination, Risk Management mitigations)
• lead test execution throughout the entire development effort across the medical diagnostic
  device and its subsystems (test Personnel capability & capacity, test Equipment development &
  qualification, test Vendors partnerships)
• report test outcome with traceable objective evidence to support unbiased technical and
  project decisions (Defects report, Statistical significance, Technical/Design reviews, Regulatory
  Agency/Notified Bodies submissions)
• ensure objective evidence traceability throughout the entire product development lifecycle
  (Raw data & records retention, Quick access to multiple layers of information, Design History
  File)
• champion the adoption and execution of a Shift left strategy through System Design
  Integration/Verification process improvements and state-of-the-art best practices (Design for Six
  Sigma, Continuous Integration tools, LEAN management, Design Control)
• leverage a global talent pool (France, Switzerland, USA) 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
• eventually be able to lead a systems Integration/Verification team and implement functional 
  management processes and tools to monitor progress of engineering deliverables across the 
  portfolio

What employer offers:

• an attractive, challenging job in an interdisciplinary R&D teams
• access to a comprehensively equipeed lab
• a great deal of autonomy and opportunities to growth
• private medical care
• sports card
• sharing the costs of professional training & courses
• flexible working hours