Biomedical Engineer Job description:
• Take part in product development throughout product life cycle
• Define and supervise the execution of V&V masterplan and bench tests to ensure product compliance with applicable standards
• Prepare V&V protocols and reports
• Define and write testing/manufacturing/inspection work instructions
• Support engineering, manufacturing and QC activities
• Define requirements for testing and inspection setups
• Manage 3rd party testing and validation activities
• Participate in ECO and MRB processes
• Work closely with other R&D, QA, Regulatory and product team members.
Required skills:
• Biomedical/Mechanical engineer from Technion or known university
• At least 3 years of proven experience in medical device industry-required
• Experience with validation of medical devices -required
• Excellent technical writing skills (English and Hebrew)- required
• Experience in implantable orthopedic products -strong advantage
• Experience in a QMS environment
• Familiarity with ISO 13485
• Responsible, hands-on approach