02 oct
|
Gilero, A Sanner Group
|
Tijuana
02 oct
Gilero, A Sanner Group
Tijuana
Do you have a passion for helping launch and manufacture innovative medical and drug delivery devices that can help improve lives? We are growing and looking for a Design Transfer Engineer to help create innovative solutions for patients and customers by managing technical risks and ensuring high-quality outcomes, Gilero, A Sanner Company, partners with Tecma to operate a medical device manufacturing facility in Tijuana, Mexico. We are currently seeking a Design Transfer Engineer to join the TJ team
Design Transfer Engineers draw on experience to bridge product development and manufacturing, taking a medical device from late-stage development through manufacturing readiness and commercial launch. They coordinate technical, quality, operational, and project activities to ensure the product can be manufactured consistently, compliantly, and at the required scale.
Collaborate with the product development and manufacturing team to identify and mitigate risks prior to commercial launch Prepare programs for pilot/development GMP builds for design verification, clinical trials, etc.
Support sustaining engineering activities for products in commercial manufacturing Maintain and develop Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and nonconformances Facilitate design transfer of existing products to and from other manufacturing sites Track technical risk and provide engineering guidance Seek feedback and mentorship from senior engineers Help lead the development team through technical risk retirement.
Create, review, and release documents according to Gilero's QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements Keep project managers informed on technical projects variables and status Prepare documentation to support design history files and regulatory submissions Analyze test data, interpret results, formu
📌 Design Transfer Engineer (Tijuana)
🏢 Gilero, A Sanner Group
📍 Tijuana