דרושים בתחום הנדסה ביו רפואית

Primary Duties and 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, including test method validation.
3. Execution of test plans and protocols; and resolving deviations.
4. Risk management review of design control documentation for development project(s)

Authorities
· V&V Master Plan Approval
· V&V doc. Approval
· Test Method Validation approval

Required Qualifications:
· Education: B.Sc. in Engineering or other related discipline
· Experience: At least 2 years’ experience in V&V positions, Medical device experience- an advantage, Experience in creating design verification plans and protocols- an advantage.

Knowledge, Skills and Abilities:
· 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
Languages:
English: Hebrew:
 Fluent- Speaking/ Writing/ Reading

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

Job 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.
At list 2 years’ experience in V&V role.
At list 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.
· Ability to manage a team- resolve conflicts, prioritize tasks, and foster effective communication between direct reports.
· Ability to mentor subordinates and guide their professional development.
· Ability to adapt to a dynamic environment while working on multiple projects in parallel.