Nous utilisons des cookies afin de vous rendre la navigation sur notre site Web plus agréable. Afin de respecter la Directive relative à la Confidentialité Electronique, nous devons vous demander l’autorisation de mettre en place ces cookies.

Recruteurs

Senior Software Engineer, Medical Devices (H/F)

col-narrow-left   

N° de l'annonce:

60214

Catégorie:

Informatique
col-narrow-right   

Visualisations:

726

Type de contrat:

CDI

Publiée le:

03.06.2019
col-wide   

Secteurs:

Industries: Prestataires

Etablissement:

Voisin Consulting Life Sciences (VCLS) is specialized in consulting services to innovative life sciences companies: biotechnology, medtech and pharmaceutical companies. VCLS supports its clients throughout product development from the design of global development plans and regulatory strategies to their implementation and submissions to regulatory agencies and payers. Its expertise encompasses the full spectrum of health products: drugs, biologics, cell and tissue therapies, medical devices/ digital, In-Vitro Diagnostics/CDx, combination products, as well as nutraceuticals and cosmeceuticals.
 
Our professional consultants have scientific background; they are located across Europe (London, UK; Paris & Rennes, France; Lausanne, Switzerland), the USA (Cambridge – MA, Somerville - NJ & San Francisco - CA) and Bangalore, India.
 
VCLS is constantly searching for talented people attracted by innovation, geographical and cultural diversity of the organization and its clients, and by the very rewarding and stimulating career opportunities offered to the employees.

VCLS is recruiting a : 
 
Senior Software Engineer, Medical Devices (H/F)
Location: EU (France, UK, Switzerland)

Missions:


Responsibilities:
 
  • Participate as team member in innovative and multidisciplinary digital projects in an international environment
  • Serve as in-house Digital expert for internal (i.e. knowledge management, technological intelligence, etc.) and external projects ((i.e. active participation in conferences, contribution to business development, etc.)
  • Participate to the definition and implementation of Digital regulatory strategies for MD software development, digital product positioning & market claims selection, clinical evaluation and registration of innovative medical digital systems on international market places, etc.;
  • Write, review and assemble high quality regulatory submissions and applications, such as CE mark Technical File/510(k)/DeNovo/PMA dossiers, ISO14155 Clinical Trial application/IDE packages, FDA Q-submission meeting applications, etc.;
  • Provide advice on operational and technical Digital subjects (i.e. software design & development, specification settings, software verification & validation, SW as MD qualification, risk analysis, etc.);
  • Provide support for the preparation of Agency meetings (primarily EU and US);
  • Monitor, prioritize and supervise projects’ strategy, timelines, and milestones and communicate them to the project team members;
  • Ensure compliance with regulations (i.e. MDR 2017/745, 21CFRPart800*, etc.) and applicable guidelines (i.e. ISO13485, etc.);
  • Stay up to date with Digital regulatory trends and requirements (including for cybersecurity protection, data confidentiality, etc.)
 

Profil:

 
Experience:
 
  • Senior Software Engineer with a demonstrated history of working in device Industry (i.e. medical mobile app development under iOS, etc.)
  • Capable to collect/understand software developer needs and to advise on best coding practices implementation under agile software development
  • Knowledgeable in software coding review, sprint planification, coding performance optimisation, etc.
  • Experienced in software technical documentation writing under MD requirements and in technological surveillance on best coding practices
  • Skills in standards applied for the development of software as medical devices (i.e. ISO 62304/62366) is a plus
 
Personal attributes and skills:
 
  • Excellent command of English (orally and in writing)
  • Strong written and verbal communication, presentation, and facilitation skills;
  • Strong problem solving skills;
  • Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
  • Client- and business-oriented;
  • Proven ability to meet deadlines;
  • Ability to work across multiple projects and prioritize based on timelines for client deliverables;
  • Ability to juggle multiple priorities and adapt quickly to new situations and new project demands;
  • Good command of MS Office (Word, Excel, PowerPoint) is required.

Location: EU (France, UK, Switzerland)
 
Email your CV and cover letter by clicking on the "postuler" button below.
Informations sur l'établissement
Voisin Consulting Life Sciences
64 Avenue Pierre Grenier
Boulogne, France

Téléphone: 33 (0)1 41 31 83 00
Site web: www.voisinconsulting.com

Profil de la société



Autres Postes suggérés
Titre du poste Etablissement Lieu
Product Specialist - TrakCare (H/F) Intersystems Courbevoie et Montpellier
Consultant déploiement Technique (H/F) AGFA Healthcare France Lille, Hauts-de-France
Techniciens Support Applicatif (H/F) DEDALUS France Valence, Auvergne-Rhône-Alpes
Développeur Mobile (H/F) DEDALUS France Strasbourg, Grand Est
Ingénieurs d’Application (H/F) DEDALUS France Valence, Auvergne-Rhône-Alpes