Join our Team

As our customer base and service portfolio continue to develop and grow, we welcome applications from experienced candidates looking to join our dynamic organisation.

If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the medical technology industry, then a role as a Congenius Consultant could be your next rewarding career step. Read on to find out more about our open vacancies.

Current opportunities

Consultant – Regulatory Affairs (m/f/d, 100%)

Reporting into our Head of Regulatory, Corinne Larke

Responsibilities

  • Design Control: provide active regulatory guidance to project teams during new product development process
  • Create regulatory strategy for EU and US markets
  • Provide guidance and review for DHF documents
  • Author US FDA submissions (510(k) or PMA)
  • Author CE Technical Documentation per Regulation 2017/745 (EU MDR)
  • Establish contact with EU Notified Bodies and US FDA for submissions
  • Change management: create regulatory assessments and change notifications for device changes throughout the product life cycle

Your Skills and Experience

  • At least 5 years’ experience in regulatory affairs in medical devices; experience with EU Class IIa, IIb or III, and US FDA Class II or III devices is required
  • Ideally experience with combination devices, in vitro diagnostics devices, implants, or digital health devices/devices containing software
  • Very good knowledge of EU and US medical device regulation including submission
  • Knowledge of design control process requirements and requirements for technical documentation for medical devices
  • Education in engineering or natural science, at least Master of Science (MSc)
  • Independent, self-organized and hands-on attitude
  • Systematic and analytical thinking, process-oriented and risk-based
  • Strong decision maker, takes the lead where appropriate and necessary
  • Ability to gain the trust of various stakeholders, from shop floor to management
  • Fluent in English and preferably also German

Benefits

  • You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
  • You benefit from flexible working hours and an exciting and versatile field of activity
  • You work in a company with a flat hierarchy, short decision-making processes
  • You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
  • You benefit from modern and attractive working conditions and development opportunities
  • An attractive salary and very good social benefits round off the offer

Apply for this role via our LinkedIn Jobs page

Technical Project Lead Connected Devices HW/FW and/or SaMD (m/f/d, 80-100%)

Reporting into our Head of eHealth, Paul Gardner

Responsibilities

  • Technical leadership of development of connected devices (HW/FW) and/or software development of mobile and/or web applications classified as SaMD
  • Leading the collaboration with external development partners
  • Leading and/or supporting cross functional project teams during development, review and submission of regulatory dossiers
  • Leading of system engineering and risk management activities
  • Planning and monitoring of design verification activities
  • Leading and authoring technical documentation (DHF/DMR)

Your Skills and Experience

  • BSc / MSc (Wish) in a relevant field
  • Autonomous and independent working style with at least 10 years of experience of projects with safety critical injection devices and related applications in a regulated environment
  • Team player who works efficiently in interdisciplinary teams
  • Analytical thinking and problem-solving capability
  • Excellent understanding of SW Lifecycle management IEC 62304, Electrical Safety IEC 60601-1, Risk Management ISO 14971, as well as in Cybersecurity, Data Privacy and Data Protection
  • Understanding of medical device regulations (EU/US)
  • Fluent in English and also preferably German

Benefits

  • You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
  • You benefit from flexible working hours and an exciting and versatile field of activity
  • You work in a company with a flat hierarchy, short decision-making processes
  • You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
  • You benefit from modern and attractive working conditions and development opportunities
  • An attractive salary and very good social benefits round off the offer

Apply for this role via our LinkedIn Jobs page

SME Cybersecurity for Medical Devices (m/f/d, 100%)

Reporting into our Head of eHealth, Paul Gardner

Responsibilities

  • Technical leadership of the development and adoption of cybersecurity policies and processes for medical devices in EU & US
  • Leading systems engineering and risk management activities related to cybersecurity for medical devices
  • Leading and authoring cybersecurity technical documentation for medical devices (DHF / DMR)
  • Be a security subject matter expert and respond to any security questions/requests, specialized in product security
  • Technical consultant to other members of the customer’s organization and customer’s customers, in all areas of system and software design related to security and privacy, providing detailed analysis, feedback, and other assistance as required
  • Maintain proficiency in current technology, design practices, architectures, software and networking processes, tools, and methods. Make recommendations regarding the implications and application of these advances

Your Skills and Experience

  • BSc / MSc (desirable) in a relevant field
  • Autonomous and independent working style with at least 5 years of experience of projects with medical devices and related applications in a regulated environment
  • Team player who works efficiently within interdisciplinary teams
  • Analytical thinking and problem‐solving capability
  • Excellent understanding of Cybersecurity related to medical devices for EU & US, Data Privacy and Data Protection (GDPR / HIPAA)
  • Strong experience in security and privacy in software and embedded (preferably regulated medical) systems
  • Deep knowledge and experience with security and privacy techniques and practices (threat modelling, risk analysis, encryption design and authentication methods, de-identification, key management, etc).
  • Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Regulation MDR 2017/745)
  • Fluent in English and German (desirable)

Benefits

  • You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
  • You benefit from flexible working hours and an exciting and versatile field of activity
  • You work in a company with a flat hierarchy and short decision-making processes
  • You can expect a pleasant working atmosphere, with uncomplicated and collegial cooperation
  • You benefit from modern and attractive working conditions and development opportunities
  • An attractive salary and very good social benefits round off the offer

Apply for this role via our LinkedIn Jobs page

Consultant – Design Control Parenteral Devices (m/f/d, 100%)

Reporting into our Head of Quality, Dr Dirk Hüber

Responsibilities

  • Execute projects for customers independently (usually on customer’s site) regarding design control activities for parenteral devices (prefilled syringes, pens and autoinjectors)
  • Problem solving and solution finding with the right balance between quality, compliance, and business needs (in technical, quality, compliance, organizational, leadership topics)
  • Advise and consult customers (take indirect leadership as appropriate)

Your Skills and Experience

  • At least 5 years’ experience in design control activities for medical devices, including parenteral devices (prefilled syringes, pens and autoinjectors)
  • Education in engineering or natural science, at least Master of Science (MSc)
  • Independent and self-organized
  • Systematic and analytical thinking, process-oriented and risk-based
  • Hands-on attitude
  • Strong decision maker, takes the lead where appropriate and necessary
  • Ability to gain the trust of various stakeholders, from shop floor to management
  • Fluent in English and German

Benefits

  • You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
  • You benefit from flexible working hours and an exciting and versatile field of activity
  • You work in a company with a flat hierarchy, short decision-making processes
  • You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
  • You benefit from modern and attractive working conditions and development opportunities
  • An attractive salary and very good social benefits round off the offer

Apply for this role via our LinkedIn Jobs page

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Congenius AG
Riedstrasse 1
CH-8953 Dietikon

e: [email protected]
t: +41 44 741 04 04

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