Test & Verification Engineer

Responsible for the engineering, development and validation of product test methods, and for the planning and execution of product verification and validation testing. Acts as technical owner of the test rooms and laboratories, and supports SME validation activities together with Project Management PE and Manufacturing Engineering in both strategic and operative tasks.

·       Development of test and verification plans for product changes, new products and validations.

·       Execution of product tests on devices, tube sets, single-use products and plastic components.

·       Design of test fixtures, test rigs and measurement set-ups; instrumentation and data acquisition.

·       Definition of sample sizes and acceptance criteria; statistical analysis of test data.

·       Root cause investigation of test failures; corrective actions; NGS deployment.

·       Design, development, documentation and formal validation of product and process test methods.

·       Measurement system analysis (Gage R&R), re-validation after changes, training of test personnel.

·       Technical owner of the test rooms and laboratories: organization, readiness, workload priorities.

·       Responsibility for test equipment (qualification, maintenance, calibration) and audit support.

·       Bachelor’s degree in Engineering (Mechanical, Manufacturing, Medical or Materials preferred).

·       2+ years of test, verification or manufacturing support experience with medical devices.

·       Practical experience in developing and executing test methods, protocols and reports.

·       Test method validation, measurement system analysis (Gage R&R) and statistical tools.

·       ISO 13485 / ISO 14971 and problem-solving tools (FMEA, 8D, Six Sigma).

·       CAD (SolidWorks) and SAP knowledge are a plus.

·       English B2 level (*) (spoken, written communication on daily basis); MS Office; detail-oriented, self-motivated team player with good communication skills.

·       10-20%. Occasional visits to other Novanta facilities, suppliers and external laboratories.