Description
Medical Device Design system Engineer
Job Description
Medical Device Design Process
Knowledge of Medical Device Processes such as ISO13484 standards, FDA processes such as PMA, 510k, Validation & Verification aspects
Skill2 - System Software Design
Essential Skill(s)
Skill1 - Medical Data Interface Standards
Should have knowledge of all applicable standards and their applicability.Should be updated on latest updates to these standards. Should have the relevant experience with at least one of these standards in design/development of the products. Is able to compare and recommend the appropriate standards such as for example: how is HL7v2 different from HL7v3. Should be able to compare the pros/cons of using HL7 CDA and other similar standards. Should have knowledge on IEC, IHE Archetypes, IEEE 11071 and deep understanding of at least one of the standards
Additional Skill(s)
Skill1 - Medical Data Acquisition and Storage
Recommend Database technology based on application complexity and requirements. Familiar with concepts of objected oriented and object relational databases. Recommend why to use relational vs. non-relational databases. Design of XML Schema and interfacing application code with schema elements. Data Modeling, normalization rules, Internationalization and localization concepts and implementation