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Business Process Manager Verification & DFM(m/w/x)
Process design and improvement for product verification and manufacturability of advanced self-injection devices. 5+ years process management experience in medical device or pharma industry required. Flexible hours, hybrid working policy.
Requirements
- 5+ years of relevant experience in process management within the medical device or pharmaceutical industry
- Strong knowledge of product development, verification processes, design controls, and DFM principles
- Excellent strategic thinking, problem-solving, and analytical capabilities
- Ability to influence and communicate effectively across all organizational levels
- Ability to work in a fast-paced, global environment with multiple priorities
- Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field
- Fluency in English
- Familiarity with PLM systems and digital documentation workflows
- Experience applying agile methodologies in process design
- Certification in Lean Six Sigma, Process Management or Project Management is a plus
- Training in DFM methodologies and verification standards preferred
- Experience with ISO 13485, FDA regulations, or similar compliance frameworks
- German skills are a plus
Tasks
- Design and implement end-to-end business processes for Design Verification and DFM
- Continuously improve processes related to Design, Risk Management, Testing, and Manufacturing Readiness
- Ensure compliance with regulatory and quality standards throughout the product lifecycle
- Collaborate with R&D, Quality, Regulatory, Manufacturing Engineering, Operations, and IT to harmonize processes
- Develop and maintain process documentation, including Work Instructions, Templates, and Guidelines
- Create training materials to ensure compliance with medical standards and company QMS
- Conduct workshops and training sessions to identify process gaps and support change management
- Translate business needs into functional solutions with system architects for PLM implementation
- Monitor process performance and report KPIs to drive continuous improvement
- Collect user feedback to enhance process efficiency
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- PLM systems
- Lean Six Sigma
- DFM methodologies
- ISO 13485
Benefits
Flexible Working
- Flexible hours
- Hybrid working policy
Diverse Work
- Challenging assignments
Informal Culture
- Multicultural team
- Inclusive and collaborative environment
Modern Office
- Modern working environment
- State-of-the-art facilities
Other Benefits
- Personal and professional development
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Business Process Manager Verification & DFM(m/w/x)
Process design and improvement for product verification and manufacturability of advanced self-injection devices. 5+ years process management experience in medical device or pharma industry required. Flexible hours, hybrid working policy.
Requirements
- 5+ years of relevant experience in process management within the medical device or pharmaceutical industry
- Strong knowledge of product development, verification processes, design controls, and DFM principles
- Excellent strategic thinking, problem-solving, and analytical capabilities
- Ability to influence and communicate effectively across all organizational levels
- Ability to work in a fast-paced, global environment with multiple priorities
- Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field
- Fluency in English
- Familiarity with PLM systems and digital documentation workflows
- Experience applying agile methodologies in process design
- Certification in Lean Six Sigma, Process Management or Project Management is a plus
- Training in DFM methodologies and verification standards preferred
- Experience with ISO 13485, FDA regulations, or similar compliance frameworks
- German skills are a plus
Tasks
- Design and implement end-to-end business processes for Design Verification and DFM
- Continuously improve processes related to Design, Risk Management, Testing, and Manufacturing Readiness
- Ensure compliance with regulatory and quality standards throughout the product lifecycle
- Collaborate with R&D, Quality, Regulatory, Manufacturing Engineering, Operations, and IT to harmonize processes
- Develop and maintain process documentation, including Work Instructions, Templates, and Guidelines
- Create training materials to ensure compliance with medical standards and company QMS
- Conduct workshops and training sessions to identify process gaps and support change management
- Translate business needs into functional solutions with system architects for PLM implementation
- Monitor process performance and report KPIs to drive continuous improvement
- Collect user feedback to enhance process efficiency
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- PLM systems
- Lean Six Sigma
- DFM methodologies
- ISO 13485
Benefits
Flexible Working
- Flexible hours
- Hybrid working policy
Diverse Work
- Challenging assignments
Informal Culture
- Multicultural team
- Inclusive and collaborative environment
Modern Office
- Modern working environment
- State-of-the-art facilities
Other Benefits
- Personal and professional development
About the Company
SHL Medical
Industry
Healthcare
Description
Das Unternehmen ist ein weltweit führender Anbieter im Design, der Entwicklung und der Herstellung fortschrittlicher Selbstinjektionsgeräte.
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