Roche Diagnostics Int. AG
Senior Engineer - Design Control Excellence(m/w/x)
Full-timeOn-siteSenior
Risch-Rotkreuz
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Developing injection moulding and assembly processes for self-injection devices. 5+ years in new process development and qualification in regulated industries required. Modern working environment, multicultural teams.
Requirements
- Minimum 5 years experience in New Process Development, Process and Equipment/System development and qualification in medical devices/regulated industry
- Master’s degree in engineering or life science field or equivalent experience
- Strong understanding of injection molding processes
- Hands-on experience in APQP and Control Plan
- Practical in-depth know-how and experience of quality techniques
- Experience with Six Sigma methods, QFD, Process Capability analysis, ANOVA, DMAIC, DoE, FMEA, control chart
- Experience in Measurement System Analysis (MSA) and GR&R
- Experience in GAMP5 V model and verification/validation activities
- Experience with FAT/SAT and IQ/OQ/PQ
- Great understanding and demonstrated experience in applied statistics
- Strong analytical and problem-solving skills
- Strong writing and verbal communication skills
- Experience in technical writing, risk documentation, stakeholder alignment, coaching and influence
- Fluent in written and spoken English
- Prior involvement in technology transfer projects across sites or regions
- Experience working with external suppliers on technical reviews and quality assurance
- Experience with mechanical design (CAD, tolerance analysis)
- Sigma certification (Green Belt minimum; Black Belt preferred) or equivalent demonstrated competence
- Fluent in written and spoken English
Tasks
- Support new process development
- Develop injection moulding and assembly processes
- Transfer products and processes
- Apply quality engineering skills
- Comply with medical device industry standards
- Handle projects from inception to launch
- Lead control planning activities
- Practice Quality tools (TQM, QFD, Risk Assessments)
- Evaluate control actions for processes and equipment
- Facilitate Process-FMEA and risk assessment tools
- Identify and implement risk controls
- Promote risk-based and scientific approaches
- Promote applied statistics in engineering studies
- Consolidate and review lessons learned
- Review historical data for robust processes
- Support creation of manufacturable Design Outputs
- Translate Design Outputs into DMRs
- Support process and equipment verifications
- Plan and execute validation activities
- Support qualification activities with external suppliers
- Ensure proper design and development activities
- Maintain documentation as per ISO 13485/FDA QSR
- Meet customer, quality, and compliance requirements
- Comply with FDA Quality System Regulation 21 CFR Part 820
- Comply with 21 CFR Part 11
- Comply with ISO 13485 and ISO 14971
- Adhere to applicable technical standards
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- Six Sigma
- QFD
- ANOVA
- DMAIC
- DoE
- FMEA
- control chart
- MSA
- GR&R
- GAMP5
- FAT/SAT
- IQ/OQ/PQ
- CAD
Benefits
Diverse Work
- Challenging assignments
Modern Office
- Modern working environment
Informal Culture
- Multicultural and dynamic teams
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.
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Not a perfect match?
- SHL Medical
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Produktionsmitarbeiter Spritzguss(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Senior Scientist PMQ(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Senior Scientist PMQ(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz
Developing injection moulding and assembly processes for self-injection devices. 5+ years in new process development and qualification in regulated industries required. Modern working environment, multicultural teams.
Requirements
- Minimum 5 years experience in New Process Development, Process and Equipment/System development and qualification in medical devices/regulated industry
- Master’s degree in engineering or life science field or equivalent experience
- Strong understanding of injection molding processes
- Hands-on experience in APQP and Control Plan
- Practical in-depth know-how and experience of quality techniques
- Experience with Six Sigma methods, QFD, Process Capability analysis, ANOVA, DMAIC, DoE, FMEA, control chart
- Experience in Measurement System Analysis (MSA) and GR&R
- Experience in GAMP5 V model and verification/validation activities
- Experience with FAT/SAT and IQ/OQ/PQ
- Great understanding and demonstrated experience in applied statistics
- Strong analytical and problem-solving skills
- Strong writing and verbal communication skills
- Experience in technical writing, risk documentation, stakeholder alignment, coaching and influence
- Fluent in written and spoken English
- Prior involvement in technology transfer projects across sites or regions
- Experience working with external suppliers on technical reviews and quality assurance
- Experience with mechanical design (CAD, tolerance analysis)
- Sigma certification (Green Belt minimum; Black Belt preferred) or equivalent demonstrated competence
- Fluent in written and spoken English
Tasks
- Support new process development
- Develop injection moulding and assembly processes
- Transfer products and processes
- Apply quality engineering skills
- Comply with medical device industry standards
- Handle projects from inception to launch
- Lead control planning activities
- Practice Quality tools (TQM, QFD, Risk Assessments)
- Evaluate control actions for processes and equipment
- Facilitate Process-FMEA and risk assessment tools
- Identify and implement risk controls
- Promote risk-based and scientific approaches
- Promote applied statistics in engineering studies
- Consolidate and review lessons learned
- Review historical data for robust processes
- Support creation of manufacturable Design Outputs
- Translate Design Outputs into DMRs
- Support process and equipment verifications
- Plan and execute validation activities
- Support qualification activities with external suppliers
- Ensure proper design and development activities
- Maintain documentation as per ISO 13485/FDA QSR
- Meet customer, quality, and compliance requirements
- Comply with FDA Quality System Regulation 21 CFR Part 820
- Comply with 21 CFR Part 11
- Comply with ISO 13485 and ISO 14971
- Adhere to applicable technical standards
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- Six Sigma
- QFD
- ANOVA
- DMAIC
- DoE
- FMEA
- control chart
- MSA
- GR&R
- GAMP5
- FAT/SAT
- IQ/OQ/PQ
- CAD
Benefits
Diverse Work
- Challenging assignments
Modern Office
- Modern working environment
Informal Culture
- Multicultural and dynamic teams
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SHL Medical
Industry
Healthcare
Description
Das Unternehmen ist ein weltweit führender Anbieter im Design, der Entwicklung und der Herstellung fortschrittlicher Selbstinjektionsgeräte.
Not a perfect match?
- Roche Diagnostics Int. AG
Senior Engineer - Design Control Excellence(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - SHL Medical
.Lab Engineer(m/w/x)
Full-timeOn-siteExperiencedZug - SHL Medical
Produktionsmitarbeiter Spritzguss(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Senior Scientist PMQ(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Senior Scientist PMQ(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz