Design Assurance Engineer for Medical Devices (m/f/d)

TN Germany; Berlin; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen engagierten Design Assurance Engineer. In dieser Rolle sind Sie für die Entwicklung und Überprüfung von Qualitätsplänen und Designkontrolldokumenten verantwortlich. Sie arbeiten eng mit verschiedenen Teams zusammen, um sicherzustellen, dass alle Produkte den höchsten Qualitätsstandards entsprechen. Diese Position bietet die Möglichkeit, an innovativen Projekten in einem dynamischen Umfeld zu arbeiten, das Teamarbeit und kontinuierliche Verbesserung fördert. Wenn Sie eine Leidenschaft für Qualität und Sicherheit in der Medizintechnik haben, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Mindestens 2 Jahre Berufserfahrung in der Qualitätskontrolle.
• Erfahrung in regulierten Branchen wie Medizintechnik oder Automobil.

Aufgaben

• Erstellung eines umfassenden Qualitätsplans für medizinische Geräte.
• Überprüfung von Designverifikations- und Validierungsspezifikationen.

Kenntnisse

Qualitätsmanagement

Risikomanagement

FMEA

Dokumentation

Teamarbeit

Ausbildung

Technische oder physikalische Studien

Jobbeschreibung

Social network you want to login/join with:

Design Assurance Engineer for Medical Devices (m/f/d), Berlin

col-narrow-left

Client:

Location:

Berlin, Germany

Job Category:

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

825696b9a511

Job Views:

1

Posted:

03.05.2025

Expiry Date:

17.06.2025

col-wide

Job Description:

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

As Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development.

Primary Responsibilities

Within the framework of design control:

• Support on creation of overall superior quality plan including document plan and overall VnV plan
• Review of design verification and validation test specification for medical devices (equipment and consumables)
• Review of design control documents according to GLP, GDP, CFR820
• Member of the product and design FMEA team

As a member of the risk management team according to ISO 14971:

• Contribute to the content of the risk management throughout the product development
• Review of the systematics and completeness of the risk analysis
• Evaluation of risk-reducing measures regarding impact on severity of damage and probability of occurrence
• Creation and review of the evidence for implementation and effectiveness of the measures

In cooperation with Quality Assurance and Production:

• Involvement in the preparation of test specifications and test requirements for the series testing of medical devices

Other tasks:

• Active participation in measures for synchronization and improvement of processes
• Failure analysis for field returns and during development
• Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions by quality/environmental officers and the specialist for occupational safety
• Completed technical and/or physical studies
• At least 2 years of professional experience
• Experience with product quality in a highly regulated industry (medical device, automotive, aviation etc.)
• Experience in theory and application of quality methods and techniques
• Quality-conscious, trustworthy and reliable
• Team player
• Structured and systematic way of working
• Willingness to travel to all locations and business contacts (10%)

#LI-UK1

#Berlin

Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.

Please call [phone] if you need a disability accommodation for any part of the employment process.