Staff Engineer, Advanced Operations (12-month contract)

Stryker Group; Tijuana; Presencial; MXN 926,000 - 1,297,000; Jornada completa

Descripción de la vacante

A leading medical device manufacturer in Tijuana seeks a Staff Engineer to develop and optimize manufacturing processes for new products. The ideal candidate will have a Bachelor's degree in Industrial Engineering, a minimum of 5 years’ experience in a regulated environment, and expertise in process validation and data analysis. Strong proficiency in English and advanced skills in Microsoft Office are essential. This role involves working cross-functionally with various teams to ensure compliance and quality standards.

Formación

• Minimum 5 years of experience in a manufacturing/process engineering role in medical devices.
• Strong understanding of manufacturing processes, materials, and product design.
• Experience in PFMEA, PPAP, and Control Plan development.

Responsabilidades

• Provide engineering support for new products and process introductions.
• Analyze process and equipment data, conduct experiments, and lead process review meetings.
• Ensure adherence to GMP, safety, and validation requirements.

Conocimientos

Process validation

Data analysis

Textiles manufacturing

Advanced English

Microsoft Office proficiency

Educación

Bachelor’s degree in Industrial Engineering or related discipline

Herramientas

Analytical tools

Descripción del empleo

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 Responsibilities

• 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.