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 Strykers 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 Strykers 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:
- Bachelors 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%
Required Experience:
Staff IC
Work Flexibility: OnsiteWhat you will doAs 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 Strykers engineering and quality standards. This position will work cross...
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 Strykers 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 Strykers 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:
- Bachelors 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%
Required Experience:
Staff IC
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