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%