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Compliance Engineer (m/f/d)

Dornier MedTech Systems GmbH
Weßling

Direkt bewerben

Details zur Stelle

Vollzeit
vor 2 Tagen

Leistungen

Flexible Arbeitszeiten

Qualifikationen

Maschinenbau
Master
Bachelor
Systems Engineering
Elektrotechnik
Deutsch

Vollständige Stellenbeschreibung

Your mission

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.

Your profile

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.

Why us?

Personal induction plan and comprehensive onboarding
Flexible working hours
30 days of holiday
interesting tasks in a dynamic, international environment
Continuous training and development
Flat hierarchies
Attractive canteen
Free coffee, tea and water
Employee events
Charging stations for electric cars
Accident insurance
Employer contribution to VWL
Employee fund with various allowances and subsidies
Free language courses

About us

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.

Direkt bewerben

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