08 ago
|
Insight Global
|
Chihuahua
08 ago
Insight Global
Chihuahua
Insight Global is seeking a Senior Project Validation Engineer to support one of our top clients, Johnson & Johnson, a leading integral medical device manufacturer in Ciudad Juárez, Mexico. This individual will be responsible for leading validation activities associated with new and existing components, suppliers, and manufacturing processes. The engineer will serve as a key liaison between suppliers, manufacturing teams, quality teams, and project stakeholders to ensure successful validation and implementation of products and processes within a regulated environment. This is a long-term, 2-year contract.
Must-Have Experience
- Bachelor's degree in Engineering (Mechanical, Biomedical, Manufacturing, Industrial, or related engineering discipline). - 2-5+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or related field. - Experience leading validation projects within a regulated manufacturing environment. - Strong experience executing validation protocols, engineering builds, qualification runs, and production validations. - Experience managing cross-functional projects and coordinating with external suppliers.
- Hands-on experience utilizing Windchill PLM for product lifecycle management, document control, or engineering change activities. - Strong understanding of engineering change processes, validation documentation, and project management principles. - Excellent communication skills with the ability to work across manufacturing, quality, engineering, and supplier teams. - Ability to work on-site five days per week in the Juárez, Mexico area.
Nice-to-Have Experience
- Medical device industry experience. - Experience supporting Design Verification & Validation (V&V;) activities. - Knowledge of FDA, ISO 13485, and medical device quality system requirements. - Experience with supplier quality, component qualification, or manufacturing transfers. - Familiarity with risk management methodologies such as ISO 14971. - Experience supporting new product introductions (NPI) or remediation projects. - PMP, CQE, or other project/quality certifications
Day-to-day responsibilities include:
📌 Senior project validation engineer (Chihuahua)
🏢 Insight Global
📍 Chihuahua