Staff Engineer, Advanced Operations (12-month contract)

Stryker Professional Latin America, S. DE R.L. DE C.V.; Tijuana; Presencial; MXN 1,284,000 - 1,652,000; Jornada completa

Descripción de la vacante

A medical devices company located in Tijuana, Mexico, is seeking a Staff Engineer in Advanced Operations to support manufacturing processes for new product introductions. The ideal candidate will have a Bachelor's degree in Industrial Engineering and at least 5 years of experience in the medical device industry. Responsibilities include ensuring compliance with engineering standards, conducting capability studies, and leading process improvements. The position offers onsite flexibility with a 10% travel requirement.

Formación

• Minimum 5 years of experience in a manufacturing/process engineering role in medical devices.
• Experience with capability studies and data analysis.
• Strong understanding of manufacturing processes and product design.

Responsabilidades

• Provide engineering support for new products and process introductions.
• Ensure adherence to GMP and safety requirements.
• Conduct capability studies and MSA for new products.

Conocimientos

Manufacturing processes

Process validation

Data analysis

Advanced English

Microsoft Office

Educación

Bachelor’s degree in Industrial Engineering

Descripción del empleo

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 textiles 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.
• Ability to interpret complex engineering drawings and apply GD&T (Geometric Dimensioning and Tolerancing) principles.

Travel Percentage: 10%