Design Transfer Engineer

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, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals) Support delivery of project objectives and milestones Participate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements Support product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering Support test method development and validation Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds Support investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering

Minimum 3 years' experience in medical device manufacturing. Skilled at transforming technical situations into well-defined project deliverables Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing Ability to support and document appropriate scenarios for rationale-based decisions versus testing-based approaches Proficient in conversational English.

Commitment to excellence and quality service to external and internal customers Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration.