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Intern / Working Student - Technical Documentation & Quality Assurance (m/f/d)

UniWearablesvor 2 TagenWerkstudent
Vor OrtEnglisch erforderlichIngenieurwesenQualitätsmanagement

Erforderliche Skills

Quality AssuranceDesign ControlsTraceabilityMDRRegulatory AffairsISO 13485VerificationTechnical Documentation

Stellenbeschreibung

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Beschreibung bereitgestellt von UniWearables

About Us

At UniWearables (www.uniwearables.com), we are building an innovative patient-monitoring platform for continuous vital-sign monitoring in clinical environments and selected dual-use applications.

Our mission is to improve the quality and speed of clinical diagnostics through continuous, intelligent patient monitoring - helping healthcare professionals make better decisions, save lives, and improve clinical outcomes.

We are led by experienced entrepreneurs with a successful MedTech exit and backed by leading venture-capital firms, high-profile private investors, and senior advisors. We collaborate closely with leading scientists and physicians, including partners at Charite - Universitatsmedizin Berlin and the Center for Space Medicine & Extreme Environments.

Following our recently closed seed financing round, we are entering a decisive phase: bringing our solution to market, scaling commercial activities, and building additional business areas around our technology platform.

About the Role

We are seeking a highly motivated intern or working student to support technical documentation and quality assurance activities for CE marking under the EU Medical Device Regulation (MDR).

Over the course of product development, our multidisciplinary team has generated a broad body of design, development, verification, and quality documentation. As the product progresses towards regulatory submission, this information is being systematically reviewed, consolidated, and aligned to ensure clear traceability and a complete technical documentation package. This work will support a robust, coherent, and review-ready demonstration of the product's development and compliance.

Working with our multidisciplinary team, you will review product-development documentation - including requirements, design outputs, test evidence, and quality records - and help establish clear traceability between development activities and objective evidence. You will identify gaps or inconsistencies, support the completion and organisation of documentation, and help ensure that records are complete, consistent, appropriately controlled, and aligned with internal procedures.

This role requires a structured and analytical approach, attention to detail, and the confidence to proactively engage colleagues to clarify information and obtain required evidence. It offers practical experience of product development, document and record control, design controls, and quality assurance in a medical-device environment.

Your Responsibilities

  • Review existing product-development, verification, and quality documentation.
  • Support requirements reviews and establish traceability between requirements, design outputs, and test evidence.
  • Identify missing, inconsistent, or unclear documentation and maintain an overview of open actions.
  • Work with engineers and other team members to clarify development activities and obtain necessary information and records.
  • Help organise and consolidate documents into a complete, structured, and review-ready technical documentation package.
  • Support document and record control activities, including checking completeness, consistency, version status, and approval information.
  • Contribute to quality assurance activities by reviewing documentation against internal procedures and applicable regulatory requirements.

Your Profile

  • You are currently pursuing a Bachelor's or Master's degree in biomedical engineering, medical technology, engineering, quality management, regulatory affairs, or a related field.
  • You have an interest in medical devices, product development, quality assurance, and regulatory affairs.
  • You have strong organisational and analytical skills.
  • You are comfortable working independently with incomplete or scattered information.
  • You have good communication skills and are willing to proactively engage with different team members.
  • You work carefully and in a structured way.
  • You are fluent in English.
  • You can work from Berlin or relocate to Berlin for the internship period.

We do not expect your profile to match every requirement. If you are interested in product development, quality assurance, and regulatory affairs, we encourage you to apply.

What We Offer

  • A modern office in Charlottenburg, with a collaborative and energetic team atmosphere.
  • Short communication paths and the opportunity to work closely with a multidisciplinary MedTech team.
  • Practical exposure to a product moving towards market access and regulatory submission.

Ready to Apply?

We are looking forward to your CV and Cover letter, apply via email at [email protected] or LinkedIn.

Wichtiges für Werkstudierende

Was diese Werkstudentenstelle im Bereich Ingenieurwesen in Berlin für dich bedeutet: die Wochenstundenregeln, die Vorteile bei den Sozialabgaben und worauf internationale Studierende vor der Bewerbung achten sollten.

Wochenstunden

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Sozialabgaben

Dank des Werkstudentenprivilegs zahlst du keine Beiträge zur Kranken-, Pflege- und Arbeitslosenversicherung — nur die Rentenversicherung greift. Dir bleibt mehr netto als in einem regulären Job.

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Studierende von außerhalb der EU dürfen 140 volle oder 280 halbe Tage im Jahr arbeiten (seit März 2024, zuvor 120/240). Ein Werkstudentenvertrag passt meist in diesen Rahmen — prüfe die genauen Grenzen auf deinem Aufenthaltstitel.

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