Stryker Leibinger GmbH & Co. KG
Staff Embedded Verification Engineer(m/w/x)
Full-timeOn-siteExperienced
Freiburg im Breisgau
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INIntuitive
Quality Engineer(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteSenior
Nejo AI Summary
Defining practical quality metrics and specifications for robotic-assisted surgery systems. 5+ years of quality engineering experience in medical devices required. Fixed-term maternity cover for 18 months.
Requirements
- Bachelor degree in electrical, mechanical or system engineering, math, or physics
- Advanced degree preferred
- 5+ years of working experience in Quality Engineering
- Minimum 3 years in medical device design or manufacturing environment
- Navigate quality and compliance system with minimal oversight
- Understanding of CFR 21 820 / ISO 13485 requirements
- Understanding of MDSAP and MDR requirements
- Knowledge in product risk management
- Experience in generating FMEA and process FMEA
- Knowledge in Design Controls, Change Controls, Product, and Engineering Processes
- Proficient with generating and executing Qualification and Validation protocol
- Proficient with generating and executing Quality Assurance Procedures
- Experienced in leading product containment and rework activities
- Proficient in SPC & Six Sigma methodology and tools
- Uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram
- Knowledge in typical Excel data analysis operations
- Capable to create Multi-source report, trends, and interprets data with minimal oversight
- Capable of thinking independently and make decision based on limited information
- Capable of initiating improvement discussion and lead the team toward the goal
- Present information in various forms and forums
- Collaborates with peers across functions
- Experience in presenting to cross functional mgmt. communications
- Excellent creative problem-solving skills
- Excellent communication and documentation skills
Tasks
- Define practical quality metrics and specifications
- Identify opportunities for product improvement
- Launch and lead quality initiatives
- Serve as a technical consultant for quality issues
- Coach and mentor engineering staff in quality practices
- Handle projects for various product types
- Develop measurable quality goals
- Lead Quality Table meetings
- Ensure performance aspects are mitigated in quality plans
- Guide engineers on regulatory and statutory requirements
- Plan and create quality standards and procedures
- Design comprehensive procedures for process compliance
- Analyze and disposition discrepant material
- Support manufacturing processes and failure analysis
- Qualify tooling and inspection methods
- Develop and execute process validation and verification plans
- Support manufacturing line qualification
- Drive SMVP/R projects
- Analyze product failures
- Perform deep technical failure analysis
- Review and interpret complex data analysis
- Create and process Quality Notifications and Change Orders
- Apply corporate quality metrics
- Lead quality meetings and reviews
- Manage quality initiatives in focus areas
- Perform mock audits and Gemba walks
- Undertake other Quality Engineering tasks as directed
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Excel
Benefits
Other Benefits
- Fixed-term position for 18 months
- US Export Administration Regulations compliance
- Export license application support
- Technology Control Plan (TCP) implementation support
Generous Parental Leave
- Maternity leave cover
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Intuitive and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Quality Engineer(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteSenior
Nejo AI Summary
Defining practical quality metrics and specifications for robotic-assisted surgery systems. 5+ years of quality engineering experience in medical devices required. Fixed-term maternity cover for 18 months.
Requirements
- Bachelor degree in electrical, mechanical or system engineering, math, or physics
- Advanced degree preferred
- 5+ years of working experience in Quality Engineering
- Minimum 3 years in medical device design or manufacturing environment
- Navigate quality and compliance system with minimal oversight
- Understanding of CFR 21 820 / ISO 13485 requirements
- Understanding of MDSAP and MDR requirements
- Knowledge in product risk management
- Experience in generating FMEA and process FMEA
- Knowledge in Design Controls, Change Controls, Product, and Engineering Processes
- Proficient with generating and executing Qualification and Validation protocol
- Proficient with generating and executing Quality Assurance Procedures
- Experienced in leading product containment and rework activities
- Proficient in SPC & Six Sigma methodology and tools
- Uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram
- Knowledge in typical Excel data analysis operations
- Capable to create Multi-source report, trends, and interprets data with minimal oversight
- Capable of thinking independently and make decision based on limited information
- Capable of initiating improvement discussion and lead the team toward the goal
- Present information in various forms and forums
- Collaborates with peers across functions
- Experience in presenting to cross functional mgmt. communications
- Excellent creative problem-solving skills
- Excellent communication and documentation skills
Tasks
- Define practical quality metrics and specifications
- Identify opportunities for product improvement
- Launch and lead quality initiatives
- Serve as a technical consultant for quality issues
- Coach and mentor engineering staff in quality practices
- Handle projects for various product types
- Develop measurable quality goals
- Lead Quality Table meetings
- Ensure performance aspects are mitigated in quality plans
- Guide engineers on regulatory and statutory requirements
- Plan and create quality standards and procedures
- Design comprehensive procedures for process compliance
- Analyze and disposition discrepant material
- Support manufacturing processes and failure analysis
- Qualify tooling and inspection methods
- Develop and execute process validation and verification plans
- Support manufacturing line qualification
- Drive SMVP/R projects
- Analyze product failures
- Perform deep technical failure analysis
- Review and interpret complex data analysis
- Create and process Quality Notifications and Change Orders
- Apply corporate quality metrics
- Lead quality meetings and reviews
- Manage quality initiatives in focus areas
- Perform mock audits and Gemba walks
- Undertake other Quality Engineering tasks as directed
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Excel
Benefits
Other Benefits
- Fixed-term position for 18 months
- US Export Administration Regulations compliance
- Export license application support
- Technology Control Plan (TCP) implementation support
Generous Parental Leave
- Maternity leave cover
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Intuitive and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Intuitive
Industry
Healthcare
Description
The company is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care.
Not a perfect match?
- Stryker Leibinger GmbH & Co. KG
Staff Embedded Verification Engineer(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau - Ormed GmbH
Mitarbeiter Qualitätsmanagement(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau - Stryker Leibinger GmbH & Co. KG
Ingenieur Fertigung & Prozessqualifizierung, Medizintechnik(m/w/x)
Full-timeTemporary contractOn-siteExperiencedFreiburg im Breisgau - TRUMPF Hüttinger GmbH + Co.KG
Quality Engineer RF/High-Frequency Technology(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau - Stryker Leibinger GmbH & Co. KG
Quality Technician - Spezialist für Qualitäts- & Prozessmanagement in Reinräumen(m/w/x)
Full-timeOn-siteExperiencedFreiburg im Breisgau