Dornier MedTech
Senior Software Engineer Embedded Systems(m/w/x)
Full-timeOn-siteSenior
Weßling
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-xx
- Codebeamer
- Polarion
- DOORS
Benefits
Mentorship & Coaching
- Personal induction plan
Other Benefits
- Comprehensive onboarding
- Accident insurance
Flexible Working
- Flexible working hours
More Vacation Days
- 30 days of holiday
Diverse Work
- Interesting tasks
Learning & Development
- Continuous training and development
- Free language courses
Informal Culture
- Flat hierarchies
Free or Subsidized Food
- Attractive canteen
Snacks & Drinks
- Free coffee, tea and water
Team Events
- Employee events
Sustainability Focus
- Charging stations for electric cars
Additional Allowances
- Employer contribution to VWL
- Employee fund with allowances and subsidies
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of DMT-Germany 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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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-xx
- Codebeamer
- Polarion
- DOORS
Benefits
Mentorship & Coaching
- Personal induction plan
Other Benefits
- Comprehensive onboarding
- Accident insurance
Flexible Working
- Flexible working hours
More Vacation Days
- 30 days of holiday
Diverse Work
- Interesting tasks
Learning & Development
- Continuous training and development
- Free language courses
Informal Culture
- Flat hierarchies
Free or Subsidized Food
- Attractive canteen
Snacks & Drinks
- Free coffee, tea and water
Team Events
- Employee events
Sustainability Focus
- Charging stations for electric cars
Additional Allowances
- Employer contribution to VWL
- Employee fund with allowances and subsidies
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of DMT-Germany 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.
Not a perfect match?
- Dornier MedTech
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