Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome engineer to join our core Validation team that is reshaping MIS.
The Configuration & control engineer will be an integral part of all Engineering prosses and has a key role in implementing quality systems to support change control. This position requires agility, attention to details, and a diversified skillset to head many different tasks and operations. If you are up for the challenge, don’t miss this opportunity, we’d love to have you on our team.
- Configuration management and Implementation of Engineering Changes/ECO.
- Providing solutions to documentation problems at production and sub Maintain configuration control in Engineering.
- Responsibility for tracking information transfer to the ERP and PDM systems.
- Responsible for training employees on records management procedures and policies, which include Engineering documentation.
- Management of product DMR including BOM, SOP’s, Mechanical & electrical specs.
- Execute the Enterprise Change Request Process (schedule meeting, conduct pre-reviews, establish agenda, issue minutes).
- Ensure Division and plant quality systems processes are in adherence to the Change Control Process.
- Participate in critical problem solving and advanced troubleshooting.
- Lead the establishment, automation and reporting of department and electronic system metrics.
- Bachelor’s /Master’s degree in Engineering
- Experience in implementing PLM & PDM systems
- Experience in medical device companies.
- Experience in transferring products from development to production and managing of engineering changes.
- Experience in ERP/PDM systems
- Experience in SOLIDWORKS, ePDM, Windchill
- Implementing FDA CFR part 11
- Great technical writing skills (English and Hebrew) – required
- Experience with FDA & CE audits