02 oct
|
Sanner America (formerly Gilero)
|
Baja California
02 oct
Sanner America (formerly Gilero)
Baja California
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 (Baja California)
🏢 Sanner America (formerly Gilero)
📍 Baja California