Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
4 to 12 years of experience in medical device process development or validation.
Medical device work history.
Strong experience with IQ/OQ/PQ and TMV.
Hands-on experience with medical device assemblies, preferably valves or delivery systems.
Experience in FDA-regulated environments (21 CFR 820, ISO standards).
Experience with catheter-based or minimally invasive delivery systems.
Pre-FDA or early commercialization experience.
Experience working with contract manufacturers.
Familiarity with Minitab or JMP software.