Review specifications and technical design documents to provide timely and meaningful feedback.
Designs, develops, and implements testing methods and equipment.
Creates detailed, comprehensive and well-structured test plans, protocols and reports.
Designs, develops and executes verification and validation, system and reliability tests
Plans and arranges the labor, schedules, and equipment required for testing and evaluating standard and special devices.
Identifies, records, documents and tracks defects during testing.
Provides test area with parameters for sample testing and specifies tests to be performed.
Interacts closely with Development Engineers.
Supports QA aspects of technology transfer of developed manufacturing processes and new product development from R&D to manufacturing environment
BSc. degree in Mechanical or Electrical engineering or equivalent.
2+ years relevant experience with multi-disciplinary products
Good documentation skills and ability to communicate effectively at all levels of the organization
Very good English skills (read and write)
Strong technical orientation
Experience in testing tasks including writing & executing test plans and protocols with a strong emphasis on quality assurance, problem solving, along with written and verbal skills- Significant advantage.
Formal and practical knowledge of testing methodologies-significant advantage
Experience with validation processes
Software – PLM (WCL), ALM (Qpack)
Familiar with Medical Device Quality Systems, ISO 13485:2003 and CFR21 Part 820.