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SHSHL Medical
Business Process Manager Hardware Verification & DFM(m/w/x)
Zug
Full-timeWith Home OfficeSenior
Nejo AI Summary
Designing and implementing business processes for hardware verification and DFM in medical devices. 7+ years of process management experience in the medical device industry required. Flexible hours, hybrid work, and a multicultural team.
Requirements
- 7+ years of relevant experience in process management
- Success in process management within medical device/pharma industry
- Strong knowledge of hardware product development
- Strong knowledge of Verification processes
- Strong knowledge of Design Controls
- Strong knowledge of DFM principles
- Excellent strategic thinking capabilities
- Excellent problem-solving capabilities
- Excellent analytical capabilities
- Focus on continuous improvement
- Focus on innovation
- Ability to influence across organizational levels
- Ability to communicate effectively across organizational levels
- Promoting transparency
- Promoting collaboration
- Ability to work in fast-paced environment
- Ability to work in global environment
- Ability to work 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
- Familiarity with digital documentation workflows
- Experience applying agile methodologies in process design
- Certification in Lean Six Sigma, Process Management or Project Management (e.g. PMI, IPMA) is a plus
- Training in DFM methodologies preferred
- Training in Verification standards preferred
- Experience with ISO 13485
- Experience with FDA regulations
- Experience with similar compliance frameworks
- German skills are a plus
Tasks
- Design, implement, and improve business processes for Design Verification and DFM
- Ensure compliance with regulatory and quality standards
- Collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, and IT
- Harmonize processes and documentation with production requirements
- Develop and maintain process documentation and training materials
- Conduct workshops and training sessions to identify process gaps
- Support change management initiatives
- Translate business needs into functional solutions
- Implement and validate PLM solutions with system architects
- Monitor process performance and report KPIs
- Collect user feedback for continuous improvement
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- PLM systems
- Signavio
- ISO 13485
- FDA regulations
Benefits
Flexible Working
- Flexible hours
- Hybrid working policy
Informal Culture
- Multicultural team
- Inclusive environment
- Collaborative environment
- Sense of belonging
Modern Office
- Modern working environment
- State-of-the-art facilities
Modern Equipment
- State-of-the-art technologies
Purpose-Driven Work
- Meaningful exchange
Other Benefits
- Shared growth
Learning & Development
- Personal development opportunities
- Professional development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SHL Medical 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.
SHSHL Medical
Business Process Manager Hardware Verification & DFM(m/w/x)
Zug
Full-timeWith Home OfficeSenior
Nejo AI Summary
Designing and implementing business processes for hardware verification and DFM in medical devices. 7+ years of process management experience in the medical device industry required. Flexible hours, hybrid work, and a multicultural team.
Requirements
- 7+ years of relevant experience in process management
- Success in process management within medical device/pharma industry
- Strong knowledge of hardware product development
- Strong knowledge of Verification processes
- Strong knowledge of Design Controls
- Strong knowledge of DFM principles
- Excellent strategic thinking capabilities
- Excellent problem-solving capabilities
- Excellent analytical capabilities
- Focus on continuous improvement
- Focus on innovation
- Ability to influence across organizational levels
- Ability to communicate effectively across organizational levels
- Promoting transparency
- Promoting collaboration
- Ability to work in fast-paced environment
- Ability to work in global environment
- Ability to work 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
- Familiarity with digital documentation workflows
- Experience applying agile methodologies in process design
- Certification in Lean Six Sigma, Process Management or Project Management (e.g. PMI, IPMA) is a plus
- Training in DFM methodologies preferred
- Training in Verification standards preferred
- Experience with ISO 13485
- Experience with FDA regulations
- Experience with similar compliance frameworks
- German skills are a plus
Tasks
- Design, implement, and improve business processes for Design Verification and DFM
- Ensure compliance with regulatory and quality standards
- Collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, and IT
- Harmonize processes and documentation with production requirements
- Develop and maintain process documentation and training materials
- Conduct workshops and training sessions to identify process gaps
- Support change management initiatives
- Translate business needs into functional solutions
- Implement and validate PLM solutions with system architects
- Monitor process performance and report KPIs
- Collect user feedback for continuous improvement
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- PLM systems
- Signavio
- ISO 13485
- FDA regulations
Benefits
Flexible Working
- Flexible hours
- Hybrid working policy
Informal Culture
- Multicultural team
- Inclusive environment
- Collaborative environment
- Sense of belonging
Modern Office
- Modern working environment
- State-of-the-art facilities
Modern Equipment
- State-of-the-art technologies
Purpose-Driven Work
- Meaningful exchange
Other Benefits
- Shared growth
Learning & Development
- Personal development opportunities
- Professional development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SHL Medical 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.
About the Company
SHL Medical
Industry
Healthcare
Description
Das Unternehmen ist ein weltweit führender Anbieter im Design, der Entwicklung und der Herstellung fortschrittlicher Selbstinjektionsgeräte.