Process validation & NPI engineer

Position: Process Validation & NPI Engineer

LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.

LTS´ commercial offering encompasses more than 20 marketed products

LTS operates today from 5 sites: Netanya, Israel, Adrenarche, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA, and Shanghai, China.

We are looking for an excellent Process validation & NPI engineer

to join our team in Israel.

The position is hybrid - 4 days a week from the office, and 1 day from home.

Job Description:

As a Medical Devices Process 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.
• Participate in departmental tasks of manufacturing engineering processes under medical devices standards – products and process work instructions, maintaining, problem solving, design reviews presentations, and critical/root cause analysis.
• Work closely with R&D, Quality Assurance, Regulatory Affairs, supply chain and other departments to lead new products process validations.

Job Requirements:

• Education: BSC in Biomedical/Mechanics/Biotechnology/Materials Engineering
• Job skills:
  • Experience of 1-3 years in medical device industry - an advantage
  • Previous experience in medical device validation or a related field, regulated environment, following development standards- an advantage
  • knowledge of regulatory requirements for medical devices
  • Testing of HW, SW, and mechanical sub-systems
  • Experience with sterilization, reliability, and biocompatibility testing - Advantage
  • Proven analytical, problem-solving, and troubleshooting skills
  • Detail-oriented with a commitment to producing high-quality documentation processes.
• Computer skills:
  • Full control of all MS Office applications.
• Language skills: Fluent English – written and spoken.
• Personality:
  • Responsible, motivated, meticulous, proactive, analytical mind, creative, expressive, excellent organizational skills, friendly.