SHL Medical
Equipment and Automation Engineer (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Zug
SHSHL Medical
Process and Validation Engineer (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Leading process introduction and CQV for self-injection devices. 3+ years process SME experience in high-volume medical device production required. Flexible hours, hybrid work, challenging assignments.
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Anforderungen
- Minimum 3 years relevant experience as Process Engineer or Validation Engineer
- Experience preferably in medical device industry
- Process SME experience in high-volume production
- Knowledge of medical device regulations (cGMP, ISO13485, CFR 820)
- Understanding of quality systems in medical device industry
- Statistical analysis knowledge and DOE execution/interpretation
- Knowledge of problem-solving and RCA methodologies
- Six Sigma certification is a plus
- Ability to perform multiple tasks and prioritize workload
- Effective analytical, technical, and problem-solving skills
- Excellent intercultural and interdisciplinary communication skills
- Ability to work independently with attention to detail
- Focus on efficiency, effectiveness, and cost
- Passionate and committed self-starter with 'can do' attitude
- Team player and taking responsibility to get job done
Aufgaben
- Act as a process SME, leading process introduction and development
- Lead process troubleshooting and improvement initiatives
- Support process introduction and development
- Support process troubleshooting and improvement initiatives
- Lead acceptance and CQV activities for production equipment
- Support acceptance and CQV activities for production equipment
- Lead acceptance and CQV activities for production processes
- Support acceptance and CQV activities for production processes
- Develop and author compliant validation plans and protocols
- Support associated change control processes
- Collaborate internally to drive improvements to production equipment
- Collaborate across departments to drive improvements to production equipment
- Collaborate internally to drive improvements to associated processes
- Collaborate across departments to drive improvements to associated processes
- Work with the validation team to drive validation process updates
- Drive efficiency in validation process updates
- Drive simplicity in validation process updates
- Drive robustness in validation process updates
- Provide input to validation-related SOPs, work instructions, and guidelines
- Make updates to validation-related SOPs, work instructions, and guidelines
- Improve the overall validation lifecycle
- Work with fellow engineers to drive root cause analysis
- Support root cause analysis
- Work with fellow engineers to drive NCMR investigation
- Support NCMR investigation
- Work with fellow engineers to drive CAPA planning
- Support CAPA planning
- Provide support for internal audits
- Provide support for external audits
- Provide support for investigations through validation documentation ownership
- Provide support for investigations through technical SME input
- Remain up-to-date with industry trends
- Ensure compliance with industry trends
- Ensure compliance with Quality Systems
- Ensure compliance with ISO13485
- Ensure compliance with cGMP
- Ensure compliance with other relevant regulatory protocols
- Perform other related duties as assigned
Berufserfahrung
3 Jahre
Ausbildung
Abgeschlossene BerufsausbildungODER
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible hours
- Hybrid working policy
Abwechslungsreiche Aufgaben
- Challenging assignments
Startup-Atmosphäre
- Fast-growing and innovative industry
Lockere Unternehmenskultur
- Multicultural team
- Inclusive and collaborative environment
- Sense of belonging
Modernes Büro
- Modern working environment
Moderne Technikausstattung
- State-of-the-art facilities and technologies
Sinnstiftende Arbeit
- Meaningful exchange
Sonstige Vorteile
- Shared growth
- Global organization
Weiterbildungsangebote
- Personal and professional development opportunities
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens SHL Medical erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei SHL MedicalÜber das Unternehmen
SH
ManufacturingZug
Das Unternehmen ist ein weltweit führender Anbieter im Design, der Entwicklung und der Herstellung fortschrittlicher Selbstinjektionsgeräte.
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