Join our team

You will be part of a multidisciplinary team in the field of medical engineering. You’ll be working on innovative and high tech implantable products.
From this perspective, the missions will be as follows:

• Have an active participation in the development of a new transcatheter delivery system, for implantable leadless pacemaker with innovative technology
• Assumed role of project leader to design a novel product architecture with plastic parts for industrial phase
• Worked with Computer Aid Design on SolidWorks software for part, assembly and drawing
• Managed the implementation of mechanical tests in the laboratory in order to demonstrate the feasibility driven by clear requirements (control tools, measurement and validation equipment, test benches, ESD constraints …)
• Participation in collaborative research and innovative projects
• Interact closely with electronical team as well as with critical suppliers and sub-contractors
• Be in charge of mechanical oriented part of deliverables
• Resolves engineering problems in a timely manner with little direction from manager
• Reports in French and English
• Contributes to patent and intellectual property “ activities awarded “Participate in the writing and updating of technical documentation
  Evolve in a quality and normative system in English (ISO 9001, ISO 13486)

Professional skills
Team work
Autonomy
Rigor

Education
Bac +2 or more

Contract and Salary
Permanent contract
Salary according to diploma and experience
Some travel required

You will be part of a multidisciplinary team in the field of medical engineering. You’ll be working on innovative and high tech implantable products.
From this perspective, the missions will be as follows:

• Technician tests
• Participate in the development of innovative products
• Assemble sub-assembly and complete products
• Perform product tests
• Prepare and perform laboratory tests
• Participate in the development of test procedures in collaboration with the electronics and mechanics engineering teams
• Analyze the results in coordination with the Design Office
• Participate in the continuous improvement of assembly processes and tools
• Study the industrial feasibility of the assembly process to ensure the cost-effective manufacturing of products
• Validate processes by creating digital and / or physical layouts
• Organization of industrial systems & logistics
• Participate in the writing and updating of technical documentation
• Evolve in a quality and normative system in English (ISO 9001, ISO 13486)

Professional skills
Team work
Autonomy
Rigor

Education
Bac +2 or equivalent

Contract and Salary
Permanent contract
Salary according to diploma and experience
Some travel required

Are you QA expert in the field on active implants? Do you want to save patients’ lives? Would you like to be part of the pioneers in the development of a cutting-edge pacemaker solution?  
If you have a Bac +5-degree, excellent relationship building and communication skills, and you have at least 5 years of experience in a similar environment, look no further and apply with us today

The Company
Cairdac SAS develops a pacemaker that incorporates a revolutionary energy harvesting module capable of powering the device with no energy life limitation.
In the middle of our development, we are looking for a Quality Assurance Engineer / Senior Specialist to assist us under the responsibility of the QARA Director.

What you will do

• As QA Engineer, you will be playing the key role in the development and implementation of the Quality Management System
• Support the development of the Regulatory Dossier for our pacemaker system.
• Management of the Risk Management File including Usability and application of the applicable technical standards for risk reduction
• Work closely with R&D teams to support the implementation of the DHF in compliance with regulatory requirements
• Assist in the safety testing of the product for risk reduction to the state of the art
• Potential overlap with validation activities such as IQ, OQ, PQ
• Quality /Regulatory review of technical reports
• Continue the implementation, maintenance and improvement of the QMS
• Conduct internal and supplier audits
• Assist to audits and follow up of results
• Work cross-functionally in identifying and resolving miscellaneous quality issues, participate in CAPA management

Who You Are
Cairdac SAS’ ideal QA / QM candidate should have experience in the development of implantable stimulators or in the field of active implants in a start-up environment

You have:
A minimum of 5 years of hands on experience in Quality Assurance / Management in active implants
Extensive knowledge of QMS (EN ISO 13485, 21 CFR Part 820, EN ISO 14971, MDR)
Familiar with technical standards (sterilization, biocompatibility, packaging, electrical safety, software..)
Knowledge of EN 45502
Excellent writing skills, both in French and English
Disciplined and very well organized

Vous êtes un expert en Assurance Qualité (QA), si possible dans les implantables actifs ? Vous voulez sauver la vie des patients ? Vous voulez être un des pionniers dans le développement d’un stimulateur cardiaque innovant ?
Si vous avez un niveau Bac +5 ou équivalant, l’habitude pour créer facilement des relations et un faible pour les communications, et vous avez au moins 5 ans d’expérience dans un environnement similaire, ne cherchez plus et postuler chez nous !

La société
Cairdac SAS développe un stimulateur cardiaque qui intègre un récupérateur d’énergie révolutionnaire, capable d’alimenter le dispositif en énergie et sans limite de temps. Dans le cadre de ce développement, nous cherchons un/une ingénieur senior en Assurance Qualité et spécialiste du management de qualité pour nous assister, qui évoluera sous la responsabilité du Directeur QA/RA.

Vos activités

• Rôle clef dans le développement et l’implémentation du QMS
• Support au développement des dossiers techniques pour notre système de stimulateur cardiaque.
• Responsable du suivi des risques produits (Risk Management File), comprenant l’utilisation et l’application des standards techniques applicable (ISO13485)
• Travailler étroitement avec les équipes de R&D pour la mise en place et le suivi des dossiers (DHF) en accord avec les recommandations réglementaires
• Assister la bonne exécution des tests de sécurité du produit pour assurer la réduction des risques (état de l’art)
• Participer aux validations des processus de fabrication (IQ, OQ, PQ)
• Supervision des rapports techniques en lien avec la qualité et règlementaire (QARA)
• Continuer l’implémentation, la maintenance et l’amélioration du QMS
• Mener des audits externes (sous-traitant) et internes puis suivre les résultats
• Identifier et résoudre les challenges qualités, participer à la gestion des CAPA

Qui êtes-vous?
Le/la candidate idéale pour Cairdac devrait idéalement avoir une expérience dans le développement de dispositif médicaux ou dans le domaine des implantables actifs, et ou une expérience dans un environnement start-up.

Vous  avez:
Au moins 5 ans d’expérience direct en Assurance Qualité / Management en implants actifs
Connaissance intensive du QMS (EN ISO 13485, 21 CFR Part 820, EN ISO 14971, MDR)
Familiarisé avec les standards techniques (stérilisation, biocompatibilité, packaging, sécurité électrique, software..) et EN455002
Capable de rédiger un dossier aussi bien en français et en anglais
Autonome, discipliné et très bien organisé