Design Control Engineer
ref. no 8178-16;
Employer:
Radiometer Sp. z o.o. Oddział w Stargardzie Szczecińskim
Employer description:
RADIOMETER. Make an impact on life. The difference between life and death can be just a few minutes. Radiometer's diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2700 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer's leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of UDS 650 million and is owned by US-based Danaher Corporation.
Requirements:
With reference to the Head of New Product Development (NPD) in R&D, you will join a team of highly skilled colleagues. NPD is responsible for development of new blood gas analysers and samplers from concept to market introduction including Design Control documentation that fulfils regulatory and internal demands. You will work closely with your Design Control Colleagues in Denmark.
Constructive Diversity is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success:
- education: Master Degree in Engineering, Pharmacy or likewise
- fluent in Polish and English both written and verbal
- experience with medical device development
- profound experience in Design Control documentation (especially within Risk Management and Requirements Engineering)
- knowledge of legislation (IVD, MDD) in EU, ISO13485, CFR Part21 and FDA guidelines on Design Control
- experience with work relations in different cultures
- use to have a cross-functional interaction
- good communication skills
- experienced MS Office user and also familiar working in databases
- systematic and structured approach to tasks and documentation
To become successful, we would like you to be:
- analytical
- organized
- team oriented
- proactive and be able to finalize tasks within deadlines
- highly self-motivated/driven
Duties:
- lead the entire Design Control documentation within one or more projects/tasks in NPD
- act as a Subject Matter Expert in Design Control
- lead the risk management process, documentation and reviews
- build up Design Control competences within NPD - focus on Stargard Poland R&D department
- participate in project management team including meetings and reporting to management
- lead the requirements engineering process, documentation and reviews
- participate in improvement processes for products development and documentation
- communicate effectively across the organization
- travel approximately 30 days per year (mainly to Denmark to coordinate with other Design Control engineers)
- work across the R&D organization and cooperate with Quality, Regulatory, Marketing, Production and other departments
Company offers:
We offer you a unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Poland and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you opportunities for further education, trainings and a range of other staff benefits
Place of work
Stargard
Forms of cooperation
full-time
Contract type
job contract
Business trips
often trips
