Required a V&V Manager.
Main Responsibilities:
1. Verifying product designs according to regulatory requirements and internal quality standards.
2. Producing and/or reviewing verification and/or validation plans, protocols, and reports.
3. Execution of test plans and protocols; and resolving deviations.
4. Risk management and review of design control documentation for development project(s).
5. Interfacing with internal and external (international) customers to define product requirement specifications and verification approaches.
6. Test method validation.
7. Manage a team of engineers- clarifying project priorities, resolving technical questions.
Delegate:
V&V Engineers.
V&V and Laboratory Manager.
Requirements:
Language Knowledge:
Hebrew: Fluent written and spoken.
English: Fluent written and spoken.
Formal Required Education and Experience: B.Sc. in Engineering or other related discipline, M.Sc. preferred. 5+ years of experience in medical device development, with 3+ years in a managerial position.
Professional required Certifications and trainings:
Design controls (21 CFR 820.30 & ISO 13485).
Risk management (EN ISO 14971).
Statistical analysis using Minitab, variable and attribute sampling, tolerance intervals, GR&R.
Familiarity with relevant medical device standards, including IEC 60601, ISO 11608, ISO 23908, ISO 80369-7, IEC 62304.
Other required soft skills:
Ability to work independently and in a cross-functional team.
Strong drive for results.
Excellent verbal and written communication skills in English.
Excellent communication and interpersonal skills.