Validation Engineer

As a Medical Devices Validation Engineer, your primary responsibility is to ensure the compliance, reliability, and functionality of medical devices throughout the product lifecycle. You will play a crucial role in developing and executing validation protocols, conducting testing activities, and collaborating with cross-functional teams to guarantee the quality and safety of medical devices in accordance with regulatory standards.

• Design validation process for manufacturing jigs and tools – from manual jigs to fully automated manufacturing system.
• Compose protocols, execute procedures and write detailed reports for various validation activities – IQ\OQ\PQ
• Design, write, perform and document test method and software validation for testing devices and software.
• Establish new manufacturing process via NPI workstreams.
• Participate in departmental tasks of manufacturing engineering processes under medical devices standards – products and process maintaining, problem solving, design reviews, and critical/root cause analysis.
• Work closely with R&D, Quality Assurance, Regulatory Affairs, and other departments to lead new products process validations.
דרישות התפקיד
• Education: B.SC. in Biomedical or Mechanical Engineering
• Job skills:
o Experience of 3 years in medical device industry
o Proven analytical, problem-solving, and troubleshooting skills
o Detail-oriented with a commitment to producing high-quality documentation processes.
o Previous experience in medical device validation or a related field - an advantage
o knowledge of regulatory requirements for medical devices – an advantage
o Testing of HW, SW, and mechanical sub-systems – an advantage
o Experience with sterilization, reliability, and biocompatibility testing - an advantage
• Computer skills:
o Full control of all MS Office applications
• Language skills: Fluent English – written and spoken.
• Personality:
o A “driver” personality, team player, meticulous, analytical mind, creative, expressive, excellent organizational skills