Dornier MedTech
Senior Software Engineer Embedded Systems(m/w/x)
Vollzeitnur vor OrtSenior
Weßling
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
DMDMT-Germany
Compliance Engineer(m/w/x)
Weßling
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Ensuring compliance with IEC 60601, MDR, and FDA requirements for medical devices. 5+ years of medical device compliance experience required. 30 days holiday, flexible working hours.
Anforderungen
- Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical discipline with strong focus on product compliance
- Minimum 5 years of proven professional experience in medical device development or compliance engineering
- In-depth understanding of relevant IEC standards for medical electrical equipment (ME equipment)
- Hands-on experience with ALM tools (e.g., Codebeamer, Polarion, DOORS)
- Solid knowledge of EMC and electrical safety principles
- Strong proficiency in systems engineering and requirements management
- Extensive experience with technical documentation and design control processes
- Professional fluency in English (written and verbal)
- German language skills are a plus
- Strong analytical capabilities and solution-oriented mindset
- Ability to precisely interpret complex standards and regulatory requirements
- Excellent communication and stakeholder management skills
- Ability to constructively and objectively challenge design decisions based on data
- Team player who thrives in an interdisciplinary, collaborative environment
- Self-motivated, structured, and detail-oriented work ethic
Aufgaben
- Identify international standards and regulatory requirements
- Translate standards into system and engineering requirements
- Create and maintain standards and compliance matrices
- Ensure compliance with IEC 60601, MDR, and FDA requirements
- Monitor and analyze updates to relevant standards
- Manage and execute electrical safety testing
- Conduct electromagnetic compatibility (EMC) testing
- Perform functional safety testing
- Ensure software lifecycle compliance
- Coordinate with external, accredited test laboratories
- Create and evaluate test plans and reports
- Resolve regulatory and technical issues during certification
- Collaborate with system architects and engineering teams
- Integrate compliance activities into product development
- Review system requirements, architecture, and design documentation
- Conduct change impact analyses for regulatory and normative impacts
- Train and guide development teams on standards and compliance
- Contribute to regulatory strategy discussions for new products
- Support global market clearance efforts
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-xx
- Codebeamer
- Polarion
- DOORS
Benefits
Mentoring & Coaching
- Personal induction plan
Sonstige Vorteile
- Comprehensive onboarding
- Accident insurance
Flexibles Arbeiten
- Flexible working hours
Mehr Urlaubstage
- 30 days of holiday
Abwechslungsreiche Aufgaben
- Interesting tasks
Weiterbildungsangebote
- Continuous training and development
- Free language courses
Lockere Unternehmenskultur
- Flat hierarchies
Gratis oder Vergünstigte Mahlzeiten
- Attractive canteen
Snacks & Getränke
- Free coffee, tea and water
Team Events & Ausflüge
- Employee events
Fokus auf Nachhaltigkeit
- Charging stations for electric cars
Sonstige Zulagen
- Employer contribution to VWL
- Employee fund with allowances and subsidies
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens DMT-Germany 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.
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DMDMT-Germany
Compliance Engineer(m/w/x)
Weßling
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Ensuring compliance with IEC 60601, MDR, and FDA requirements for medical devices. 5+ years of medical device compliance experience required. 30 days holiday, flexible working hours.
Anforderungen
- Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical discipline with strong focus on product compliance
- Minimum 5 years of proven professional experience in medical device development or compliance engineering
- In-depth understanding of relevant IEC standards for medical electrical equipment (ME equipment)
- Hands-on experience with ALM tools (e.g., Codebeamer, Polarion, DOORS)
- Solid knowledge of EMC and electrical safety principles
- Strong proficiency in systems engineering and requirements management
- Extensive experience with technical documentation and design control processes
- Professional fluency in English (written and verbal)
- German language skills are a plus
- Strong analytical capabilities and solution-oriented mindset
- Ability to precisely interpret complex standards and regulatory requirements
- Excellent communication and stakeholder management skills
- Ability to constructively and objectively challenge design decisions based on data
- Team player who thrives in an interdisciplinary, collaborative environment
- Self-motivated, structured, and detail-oriented work ethic
Aufgaben
- Identify international standards and regulatory requirements
- Translate standards into system and engineering requirements
- Create and maintain standards and compliance matrices
- Ensure compliance with IEC 60601, MDR, and FDA requirements
- Monitor and analyze updates to relevant standards
- Manage and execute electrical safety testing
- Conduct electromagnetic compatibility (EMC) testing
- Perform functional safety testing
- Ensure software lifecycle compliance
- Coordinate with external, accredited test laboratories
- Create and evaluate test plans and reports
- Resolve regulatory and technical issues during certification
- Collaborate with system architects and engineering teams
- Integrate compliance activities into product development
- Review system requirements, architecture, and design documentation
- Conduct change impact analyses for regulatory and normative impacts
- Train and guide development teams on standards and compliance
- Contribute to regulatory strategy discussions for new products
- Support global market clearance efforts
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-xx
- Codebeamer
- Polarion
- DOORS
Benefits
Mentoring & Coaching
- Personal induction plan
Sonstige Vorteile
- Comprehensive onboarding
- Accident insurance
Flexibles Arbeiten
- Flexible working hours
Mehr Urlaubstage
- 30 days of holiday
Abwechslungsreiche Aufgaben
- Interesting tasks
Weiterbildungsangebote
- Continuous training and development
- Free language courses
Lockere Unternehmenskultur
- Flat hierarchies
Gratis oder Vergünstigte Mahlzeiten
- Attractive canteen
Snacks & Getränke
- Free coffee, tea and water
Team Events & Ausflüge
- Employee events
Fokus auf Nachhaltigkeit
- Charging stations for electric cars
Sonstige Zulagen
- Employer contribution to VWL
- Employee fund with allowances and subsidies
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens DMT-Germany 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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Spezialist Reklamationsmanagement / Specialist Complaint management(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWeßling - HENSOLDT AG
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