Biomedical V&V Engineer

· Testing and validation of company’s products throughout product life cycle to comply with marketing and regulatory requirements.
· Supporting product development from initial concept though 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:
· 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 medical device industry – strong advantage
· Experience with validation of medical devices – strong advantage
· Experience in implantable orthopedic products – strong advantage
· Experience in a QMS environment – strong advantage
· Familiarity with ISO 13485 – strong advantage
· Responsible, hands-on approach