Description
REQUIRED SKILLS- Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
- Skilled in test plan development and root cause failure analysis.
- Good verbal (including presentation) and written communication skills, especially technical report writing.
PREFERRED EXPERTISE
- Familiar with reliability analysis and test methods, including HALT and HASS.
- Strong familiarity with regulatory requirements (e.g. ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820, ISO 14971, ISO 62304).
- Experience in risk evaluation techniques, such as FMEA & fault tree analysis.
- Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments.