Job Summary
As a Compliance Engineer (m/f/d), you will work closely with all R&D departments and Regulatory Affairs. In this role, you will analyze, interpret, and review regulations and standards to ensure ongoing compliance of our medical devices, software solutions, and processes. You will support our products throughout their entire lifecycle, from initial concept and development to market launch. In addition, you will translate normative requirements into technical specifications and coordinate all compliance activities with external test laboratories and regulatory authorities.
Key Responsibilities:
a) Standards & Regulatory Compliance
- Identify relevant international standards and regulatory requirements for medical devices.
- Interpret and translate standards into actionable system and engineering requirements.
- Create and maintain standards matrices, applicability matrices, and compliance checklists.
- Ensure compliance with the IEC 60601 series as well as MDR and FDA requirements.
- Monitor updates to relevant standards and conduct delta analyses to assess their impact on products.
b) Verification and Validation
- Manage and execute conformity testing in the following areas:
o Electrical safety
o Electromagnetic compatibility (EMC)
o Functional safety
o Software Lifecycle Compliance
- Coordinate and communicate directly with external, accredited test laboratories.
- Create and evaluate test plans and test reports regarding potential compliance deviations.
- Independently resolve regulatory and technical issues during certification testing.
c) Product Development Support
- Collaborate closely with system architects and engineering teams during the concept, design, and verification phases.
- Ensure that all compliance activities are seamlessly integrated into the product development process.
- Review system requirements, architecture, interfaces, and design documentation.
Additional Responsibilities:
- Take ownership of change impact analyses to evaluate the regulatory and normative impact of product changes.
- Conduct training sessions and provide guidance to development teams regarding standards and compliance best practices.
- Actively contribute to regulatory strategy discussions for new products and global market clearances.
a) Education
- Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline with a strong focus on product compliance.
b) Experience & Technical Skills
- Minimum of 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):
o IEC 60601-1 (General requirements for basic safety)
o IEC 60601-1-2 (Electromagnetic compatibility / EMC)
o IEC 60601-1-6 (Usability)
o IEC 60601-2-xx (Product-specific particular standards)
- 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) for international collaboration with regulatory bodies and test laboratories (German language skills are a plus).
c) Personal Attributes
- Strong analytical capabilities and a 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.
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Personal induction plan and comprehensive onboarding
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Flexible working hours
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30 days of holiday
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interesting tasks in a dynamic, international environment
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Continuous training and development
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Flat hierarchies
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Attractive canteen
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Free coffee, tea and water
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Employee events
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Charging stations for electric cars
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Accident insurance
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Employer contribution to VWL
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Employee fund with various allowances and subsidies
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Free language courses
Dornier MedTech is a medical device company headquartered near Munich, Germany, and a wholly owned subsidiary of Advanced MedTech. As a pioneer in the field of urology, Dornier is one of the most trusted names in the industry.
With the introduction of several breakthrough technologies and revolutionary therapies in recent years, we continue to drive medical performance and pioneer innovation in urology. As the world's first MDR-certified integrated urology company and one of the founders of the Urology Care Foundation (formerly known as the American Foundation for Urologic Diseases), we pride ourselves on holding ourselves to the highest standards of patient safety and product efficacy.
Today, we are setting new standards in digital urology to provide holistic care to patients seeking treatment and support the community on their road to recovery, both online and on-site.
Trusted by thousands of physicians and patients, Dornier is committed to supporting our urological communities worldwide.
