Starting with test method validation assessment documentation, develop a plan to complete validation activities of new or existing test methods and then execute on the plan.
Develop test methods for both standard's specific and product specific requirements.
Write protocols & technical reports.
Review design and process changes and assess impact to assure reliability requirements are met.
Complete Gage R&R studies on test methods used for design verification, receiving inspection, in process checks (mfg), and final QC checks (mfg).
Complete statistical analysis using Minitab on test data gathered.
|Requisitos - Requirements
Bachelor’s degree in Mechanical Engineering.
3+ years of experience in the design, qualification and manufacture of medical devices; Experience with validation of test methods.
Reliability, Design Assurance, design verification and validation testing, product development, reliability or advanced manufacturing/process development engineering functions.
Experience writing test protocols and reports. Experience with test methods. Experience with developing fixtures and basic inspection methods.
Proficiency with data analysis using statistical techniques and reliability tools.
Proficiency with Minitab, MS word and MS excel.
Demonstrated verbal and written communication skills working across departments.
Familiarity with medical device standards, processes and documentation.
Familiarity or experience in surgical procedures.