KVALITO Consulting Group is seeking a Device Technical Expert - Junior to join their team. The responsibilities of the role include compiling design control documentation, managing technical development activities, and leading collaboration with external partners. The ideal candidate has a science or engineering degree, 3+ years of experience in medical device development including pre-filled syringes, regulatory knowledge, and mechanical engineering skills. KVALITO offers competitive benefits like flexible work hours, training, and the opportunity to work on global projects.

1. We are Looking for Medical Device Experts!
KVALITO Consulting Group is a strategic life science partner with
global quality and compliance service network for the regulated life
science industry. Headquartered in Basel (Switzerland) with
subsidiaries in Prague (Czech Republic), Dresden (Germany) and Dublin
(Ireland)
Responsibilities:
Responsibilities
 Compile Design Control documentation and contributing to a high
quality Design History file.
 Planning and leading technical activities;
 Managing technical development activities in collaboration with
internal development partners;
 Leading the collaboration with external development partners:
o Monitor work progress according to plan
o Monitor, support and challenge technical development as well
as test and verification work
o Monitor development and implementation of manufacturing
processes
o Coordinate and monitor technical documentation
Minimum Qualifications and Experiences
 The successful candidate for this position will lead and support
technical activities within the development of parenteral
delivery systems, e.g. drug/device combination products and
medical devices, within the Device Team with main focus on
devices for parenteral administration.
 Master degree in Science/Engineering or Mechanical Engineering or
University level Engineering education.
 Excellent skills in English language are required.
Preferred Qualification and Experiences
An ideal candidate would have a relevant degree in engineering and at
least 3 years of experience in a similar area, including:
Life Science Consultants
Device Technical Expert - Junior

2. We are Looking for Medical Device Experts!
 Pre-filled-syringe device development, from early phase
activities up to commercialization and production scale up;
 DHF compilation, including Design Control process and other
applicable regulatory, QA and GMP aspects;
 Understanding of medical device regulations (FDA 21CFR 820, EU
Medical Device Directive);
 Mechanical engineering in general
o Product design/Design for manufacture
o Test and verification, incl. development of methods and
equipment
 Experience of managing external suppliers;
 Good communication and conflict solving skills;
 Good technical knowledge in primary containers, e.g. syringes and
cartridges
 General understanding of Human Factors Engineering and Risk
management
 Good understanding of pharmaceutical development in general.
We offer great benefits
 Flat hierarchies and responsibility from the beginning
 People-oriented culture
 Diversity and inclusion focused environment
 Global client projects in a multinational environment
 Flexible working hours and home office
 Involvement in global conferences
 Individual professional development, training and coaching
 Laptop and mobile phone
 Vacation/Leave
 Unlimited full employment contract
 Excellent remuneration package with a monthly salary plus a
substantial bonus
Contact

3. We are Looking for Medical Device Experts!
If you have the necessary background and experience and would like to
join a small team responsible for a truly global operation, then please
send your application to info@kvalito.ch including:
 Your CV
 A motivation summary (max. 5 sentences)
 The earliest starting date
 Your salary requirements
 Your availability / earliest start date
 Your preferred locations (Basel, Dublin, Prague, Dresden)