Design Transfer Engineer - Medical Device Industry

Gilero, A Sanner Group Company; Tijuana; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Gilero, A Sanner Company, is seeking a Design Transfer Engineer to bridge product development and manufacturing, moving medical devices from late-stage development to manufacturing readiness and commercial launch. You will coordinate technical, quality, operational, and project activities to ensure scalable, compliant production.

You will collaborate with customers, vendors, and internal teams to mitigate risks and develop robust test methods and protocols that meet state-of-the-art

Formación

• Minimum 3 years’ experience in medical device manufacturing.
• Understanding of GMP and GDP in medical devices.
• Familiarity with Phase Gate processes and regulatory requirements.
• Knowledge of ISO 14971, 13485 and CFR 21.
• Ability to read and interpret technical drawings and GD&T.
• Ability to apply basic statistical methods (t-test, ANOVA, UCL/LCL).
• Experience with document control and design history files (DMR).
• Proficient English communication (oral and written).

Responsabilidades

• Collaborate with product development and manufacturing to identify and mitigate risks prior to launch.
• Prepare programs for pilot/development GMP builds for design verification and trials.
• Manage product development deliverables through the development lifecycle with a focus on manufacturing transfer.
• Support sustaining engineering activities for products in commercial manufacturing.
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ).
• Maintain and develop Device Master Record (DMR) and ensure documents are complete and current.
• Participate in CAPA investigations to improve manufacturing processes.
• Facilitate design transfer of products to and from other sites.
• Track technical risk and provide engineering guidance.
• Support test method development and validation; review GD&T and drawings.
• Prepare documentation to support design history files and regulatory submissions.
• Assist with device failures investigations and root cause analysis with Quality Engineering.

Conocimientos

Medical device manufacturing

GMP/GDP knowledge

Phase Gate System

ISO 14971/13485

GD&T understanding

Statistics methods

Technical documentation

English communication

Educación

BS in Engineering or equivalent technical degree

Descripción del empleo

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. In this position you will champion teamwork and ensure seamless collaboration with customers, vendors, and internal teams.

Responsibilities

• 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.
• Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer
• Support sustaining engineering activities for products in commercial manufacturing
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
• Maintain and develop Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and nonconformances
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes
• 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. Support the team on technical risks through step-by-step simplification to discover root cause
• Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer
• 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

Skills/Qualifications:

• BS in Engineering or equivalent technical degree
• Minimum 3 years’ experience in medical device manufacturing.
• Skilled at transforming technical situations into well-defined project deliverables
• Understanding of good GMP and GDP
• Understanding of the Phase Gate System
• Exposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge base
• 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
• Ability to author scientific/logic-based rationale
• Awareness of pre-clinical validation and GLP
• Ability to review and understand technical drawings and GD&T to support development lifecycle
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)
• Excellent communication skills (oral and written). Proficient in conversational English.

Personal Attributes:

• Meets Gilero Core Values of Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors; Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind; Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems and Excellence - delivering exceptional products and services with passion and pride.
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking
• Commitment to excellence and quality service to external and internal customers
• Follow established policies and procedures, while contributing to continuous improvements

Why work at Gilero?

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. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. Locations include Tijuana, Mexico and US locations in Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.