System V&V Engineer (M/F/X)

Reposted 12 Days Ago
Be an Early Applicant
Paris, Île-de-France
In-Office
Senior level
Healthtech • Robotics
The Role
The System V&V Engineer will lead verification studies ensuring compliance with regulatory standards, develop test protocols, and collaborate with cross-functional teams in the medical device sector.
Summary Generated by Built In

Robeauté is redefining the future of neurosurgery with self-propelled microrobots designed to navigate the human brain with unprecedented precision. Our technology makes it possible to reach deep brain regions that were previously inaccessible, without invasive surgery. 

We’ve developed microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments. 

Since our founding in 2017, we’ve filed 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2026. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth. 

Now, as we scale, we are looking for a System V&V Engineer to define and lead robust system verification studies across our medical device portfolio, ensuring regulatory compliance and engineering excellence. 


What you’ll do 

System Product/Device Verification 

  • Collaborate to the definition and execution of the system-level verification strategies, ensuring full traceability to user and design requirements in compliance with our Quality Management System and design control procedures based on ISO 13485,  ISO 14971 and FDA rules and guidelines. 
  • Develop and lead functional and safety testing according to the system verification strategy, ensuring coverage and alignment with design inputs and regulatory standards (e.g., Biocompatibility following ISO 10993 series, Transport and shelf-life validation following ISO 11607, System functional integration and robustness tests) 
  • Collaborate with R&D and Product teams in the definition of verification studies they own on the hardware and software components. (e.g., based on ISO 60601-1 for electrical safety, 62304 for medical devicesoftware, IEC 80001-5-1 and IEC 82304-1 for cybersecurity). 
  • Collaborate with cross-functional teams to analyze test results, identify root causes of system issues, define corrective and preventive actions. 
  • Support validation and design transfer activities, ensuring the integrity of verification evidence in the Design History File (DHF). 
  • Cross-Functional Collaboration 
  • Collaborate closely with system, software and hardware engineering teams to ensure seamless integration of all subsystems into a unified, high-performance product. 
  • Interface with Quality Assurance, Regulatory Affairs, and Clinical teams to ensure verification deliverables meet regulatory submission and audit requirements. 
  • Participate in design reviews, risk assessments, and usability evaluations, providing system-level insight into potential design or integration issues. 
  • Contribute to continuous improvement of verification processes, test automation strategies, and system-level test methodologies. 

Training & Process Leadership 

  • Act as a technical leader within the System  team, guiding integration and verification of best practices across projects. 
  • Provide training and mentorship in her/his domain to engineers, project leads, and technical managers on regulatory expectations and engineering excellence. 
  • Support cross-functional alignment on technical decisions, risk mitigation strategies, and verification priorities. 
  • Continuously monitor industry trends and evolving standards to adapt and improve internal design control processes. 
  • Promote a culture of rigor, traceability, and regulatory discipline across the product lifecycle. 

Requirements

 Technical Skills 

  • Strong knowledge of  ISO 13485, ISO 14971, ISO 10993, ISO 11607 and FDA 21 CFR 820. 
  • Hands-on experience with ALM tools (e.g., Jama, Matrix Requirements), static analysis. 
  • Familiarity with ISO 60601-1 and collaterals standards, ISO 62304, and cybersecurity standards (e.g., FDA premarket guidance) is a plus. 

Personal Attributes 

  • Analytical, methodical, and rigorous, with a strong process orientation. 
  • Excellent communicator and trainer, able to influence cross-functional teams. 
  • Pragmatic and proactive, with a commitment to documentation and compliance. 
  • Comfortable working in a multidisciplinary and fast-paced environment. 

Education and Experience 

  • Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Systems Engineering, or related field. 
  • 5+ years of experience in system integration, verification, and design control within the medical device industry.  
  • Proven ability to develop and maintain verification documentation (V&V plans, test protocols, reports, and traceability). 

Benefits

A Mission That Matters: Join a team developing life-changing technology. Our microrobots have the potential to help over 1 million patients with neurological conditions.

World-First Innovation: Work on pioneering microrobots that navigate the brain for diagnosis and treatment—minimally invasive, maximum impact.

An Exceptional Team: Collaborate with leading engineers, clinicians, and researchers pushing the boundaries of medical robotics and neurotechnology.

Real Ownership: Join a well-funded deeptech startup backed by top investors. Shape your domain, drive strategic decisions, and grow with us.

Benefits:

Alan Health Insurance — One of France's most innovative health insurance providers. We happily cover 60% of the cost.

Meal Vouchers — €9.25 per day, We happily cover 60% of the cost.

Transportation Reimbursement — 50% of your commuting costs covered.

Top Skills

Alm Tools (E.G.
Fda 21 Cfr 820
Iso 10993
Iso 11607
Iso 13485
Iso 14971
Iso 60601-1
Iso 62304
Jama
Matrix Requirements)
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Paris
39 Employees
Year Founded: 2017

What We Do

Robeauté is pioneering a new class of therapeutic microrobots—engineered to diagnose, treat and monitor the brain with unprecedented flexibility and precision. We are a pluridisciplinary and multicultural team of passionate, supportive and creative people, at the crossroads of microrobotics, engineering and medicine. We are team players, with both classical and atypical backgrounds, so unconventional thinking is welcome and good communication skills are a must.
Our team is growing and we are constantly on the lookout for incredible talent and grit.
We are based in Paris, France.

Check out our open roles: https://apply.workable.com/robeaute/
Follow us here as we tell you more of what we do.

Similar Jobs

Navan Logo Navan

Field Marketing Manager

Fintech • Information Technology • Payments • Productivity • Software • Travel • Automation
Easy Apply
Hybrid
Paris, Île-de-France, FRA
3300 Employees

Snap Inc. Logo Snap Inc.

Lead, Sales Ops EMEA (9 Month FTC)

Artificial Intelligence • Cloud • Machine Learning • Mobile • Software • Virtual Reality • App development
Hybrid
Paris, Île-de-France, FRA
5000 Employees

Atlassian Logo Atlassian

Consultant

Cloud • Information Technology • Productivity • Security • Software • App development • Automation
In-Office or Remote
Paris, Île-de-France, FRA
11000 Employees
Hybrid
Clamart, Hauts-de-Seine, Île-de-France, FRA
90000 Employees

Similar Companies Hiring

Axle Health Thumbnail
Logistics • Information Technology • Healthtech • Artificial Intelligence
Santa Monica, CA
17 Employees
Camber Thumbnail
Social Impact • Healthtech • Fintech
New York, NY
53 Employees
Sailor Health Thumbnail
Telehealth • Social Impact • Healthtech
New York City, NY
20 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account