Work Flexibility: Onsite
**What you will do**
As a Staff Engineer in Advanced Operations, you will play a key role in developing, validating, and optimizing manufacturing processes for new product introductions, ensuring compliance with Stryker’s engineering and quality standards. This position will work cross-functionally with engineering, quality, and operations teams to deliver reliable, scalable, and compliant production solutions.
**Key Responsabilities**
- Provide engineering support for new products and process introductions, ensuring all activities comply with Stryker’s new product development procedures.
- Ensure product and process quality meet established operational and material specifications.
- Select components and equipment based on technical specifications, reliability, and regulatory requirements; collaborate with quality engineers on inspection and testing protocols.
- Support capital acquisition activities including equipment specification, contract negotiation, installation, and validation.
- Analyze process and equipment data, conduct experiments, and lead process review meetings to drive improvements.
- Participate in PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SOP (Standard Operating Procedure),



and PPAP (Production Part Approval Process) generation for product transfers and new launches.
- Conduct capability studies and MSA (Measurement System Analysis) for new products and processes, and prepare related inspection documentation.
- Ensure adherence to GMP (Good Manufacturing Practices), safety, and validation requirements in all manufacturing activities.
**What you need**
**Required**:
- Bachelor’s degree in Industrial Engineering or related engineering discipline.
- Minimum 5 years of experience in a manufacturing/process engineering role in medical devices or similarly regulated industry.
- Experience with process validation, capability studies, and data analysis.
- Experience in têxtiles manufacturing and composition.
- Strong understanding of manufacturing processes, materials, and product design.
- Advanced proficiency with Microsoft Office and analytical tools.
- Experience in PFMEA (Process Failure Mode and Effects Analysis), PPAP (Production Part Approval Process), and Control Plan development.
- Advanced English.
**Preferred**:
- Experience supporting capital equipment projects from specification through validation.
Travel Percentage: 10%

📌 Staff Engineer, Advanced Operations (12-month Contract) (Tijuana)
🏢 Stryker
📍 Tijuana