Electromechanical Medical Product Validation Specialist

2 giorni fa


Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

About Us

Baxter is a leading healthcare company that has been revolutionizing the way patients receive care for nearly 70 years. As part of our journey to separate our Kidney Care segment into a standalone company, we are seeking an experienced Electromechanical Medical Product Validation Specialist to join our team.

Salary

We offer a competitive salary in the range of $120,000 - $180,000 per year, depending on experience and qualifications.

Job Description

The successful candidate will play a key role in ensuring that our medical equipment meets regulatory requirements and specifications at system level. This will involve collaborating with multidisciplinary teams of engineers to verify technical requirements, validate intended use and user needs, and ensure safety system verification and compliance to 60601-2-16.

Key Responsibilities:

  • Coordination of Sys V&V team as technical leader
  • Verification of technical requirements
  • Validation of intended use and user needs
  • Safety system verification and compliance to 60601-2-16
  • Risk Control Measures Verification
  • Labeling and Training material Verification
  • Development of tool/test bench/test method for supporting test activities
  • Collaboration on investigation, feasibility and root cause analysis
  • Active participation in cross-functional and/or cross-sites teams
  • Support on internal and external Audit
  • Management of instruments/tools

Required Skills and Qualifications:

  • Masters Degree in Electronic Engineering or Biomedical Engineering
  • ISTQB certificate is preferred
  • 5+ years of experience working in R&D, in System V&V and experience with medical device products is preferred
  • Understanding of medical device product design and regulatory processes
  • Knowledge of applicable standards and regulations (FDA, ISO and IEC)
  • Deep knowledge of Design Control and of Design Of Experiments
  • Familiarity with Electronic and Software instruments and tools used in V&V lab
  • Familiarity with Statistical Analysis and Test Methods Validation
  • Familiarity with system design, electronics, mechanical and software integration
  • Experience with LabView and Test Stand development is preferred
  • Able to communicate effectively, both verbally and in writing, within an international and multi-site environment
  • Teamworking approach, Problem-solving attitude and ability to organize and prioritize tasks

Benefits:

  • Competitive salary
  • Opportunities for career growth and development
  • Collaborative and dynamic work environment
  • Recognition and reward for outstanding performance


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