Job Description :
JOB DESCRIPTION:
Plan and lead completion of Design Control deliverables for software in compliance with corporate SOPs and Medical Device regulations (ISO 13485, 21 CFR 820.30) and in support of project teams to meet project objectives
Plan and lead completion of Software Development deliverables in compliance with corporate SOPs and regulations (EN 62304)
Write or manage completion of Design Plans, Requirement documents, Design Documents, Risk Assessment and Risk Management File, and other associated documents in compliance with the software development SOPs.
Owns and coordinates project software change controls
Prepare, publish and lead Design Reviews, as required, in collaboration with Project Teams -Support preparation of CE Technical Files and FDA submissions and defend Design Control deliverables during audits as required
Adept at cross-functional collaboration
Assist with management of project work elements (change requests, bugs, and tasks) through development life cycle, including entering, assigning, tracking and evaluating details for completeness and compliance to SOPs and development plans.
Primary Skills:
Medical Device Industry Solid understanding of Medical Device Design Control (21 CFR 820.30, ISO 13485, EN 62304)