V&V Engineer (Medical Device)

Summary of Position:

· Testing and validation of company's products throughout product life cycle to comply with marketing and regulatory requirements.

· Supporting product development from initial concept through validations into transfer to mass production. Responsible for validations and providing required engineering and testing documentation to be included in DHF and DMR.

Duties and Responsibilities

· Takes part in product development throughout product life cycle.

· Defines and supervises the execution of V&V masterplan and bench tests to ensure product compliance with applicable standards.

· Prepare V&V protocols and reports.

· Defines and writes testing/manufacturing/inspection work instructions.

· Supports engineering, manufacturing and QC activities.

· Defines requirements for testing and inspection setups.

· Manages 3RD party testing and validation activities.

· Participates in ECO and MRB processes.

· Works closely with other R&D, QA, Regulatory and product team members.

Required skills:

· 2-4 years’ experience in V&V in the medical device industry - required

· Biomedical/Mechanical engineer from a known university – required

· Excellent technical writing skills (English and Hebrew) – required

· Independent work capability, high interpersonal skills – required

· Experience in implantable orthopedic products - strong advantage

· Experience in a QMS environment - strong advantage

· Familiarity with ISO 13485 - strong advantage

· Responsible, hands-on approach

The position is full time, on-site.

Please send your CV to [email protected]