design quality engineer to spermosens in lund

Job description
Take the chance to be a part of Spermosens, a leading developer of revolutionizing medical device products for male infertility, individualizing In Vitro Fertilization (IVF) diagnostics and treatment creating a new standard for faster and safer IVF treatments! With Spermosens first product, JUNO- Checked, it will – for the first time – be possible to determine a sperms ability to fertilize the egg cell. This in turn enables the IVF clinic to choose the appropriate fertilization treatment. Today, around 85 percent of IVF treatments fail. Being able to determine the sperm’s ability to fertilize the egg cell is expected to cause to a reduction in the number of IVF-treatments. As we are growing this is a new role and here you´ll get the chance to contribute with you expertise in design control and manufacturing for medical devices and be part of making an impact of the lives of many childless couples. 

Responsibilities
The main purpose of this role is to support the Head of Product Design and Development, who you are reporting to, in design and development projects for Spermosens in-vitro diagnostic products. You bring your expertise within manufacturing, and coordinate technical activities during development of our products, in collaboration with development and manufacturing partners. You will also spend time on leading or participating in design control activities, including managing DHFs design history file, translating customer needs and identifying design input requirements, and planning V&V activities.

Other tasks included in the role will be:
Preparation of technical documentation to support the RA Manager in submissions.
Act as a Subject Matter Expert supporting CAPA and NC investigations.
Participating in Risk Management activities.


Qualifications
To thrive and perform well in this role, we believe that you bring the following experiences and knowledge:
Academic background in engineering/biomedical engineering or similar (bachelors or masters). 
Minimum 3 years professional experience in quality engineering/R&D or equivalent within medical devices. 
Expertise in design control and manufacturing for medical devices with at least 2 years experience supporting design and development projects for medical devices. 
Experience in quality management system standard ISO 13485, FDA QSR and national regulations MDD, MDR, IVDR. 
Fluent in English, both spoken and written. 

If you also have experience in in vitro diagnostic medical devices and/or embedded software devices and experience in using eQMS it will be seen as a plus, like knowledge within Swedish. 

We are searching for you who are comfortable in this role and who wants to grow and develop with our company. You need to have excellent communication skills since the role entails contacts with different stakeholders, both internally and externally. Furthermore, you love digging into details but at the same time, you have the ability to finish your tasks and meet deadlines. 

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Please apply at the latest on 2022-04-22, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information please contact recruitment consultant Emelie Lanner, emelie.lanner@randstad.se or +46729733382.

About the company
Developer of revolutionizing medical device products for male infertility, individualizing In Vitro Fertilization (IVF) diagnostics and treatment creating a new standard for faster and safer IVF treatments. Spermosens is listed on Spotlight Stock Market since 5th of May 2021.