Design Control Specialist – Medical Devices
– Are you passionate about development of medical devices and assuring design control throughout the development processes?
– Are you competent and experienced in planning and documenting medical device activities, including risk management, in all phases of the development?
– Do you want to join an expert Design Control team at Technolution, who works dedicatedly with our clients to get new medical devices approved by the authorities?
Then join Technolution and become part of an energetic and innovative rapidly growing company, where you will boost your professional experience and knowledge, while assisting our clients in successfully launch of new medical devices.
In the job as Design Control Specialist, you will join our team of highly skilled experts in Design Control for medical devices. Your technical insight combined with your medical development experience shall ensure development of design control documentation at a correct and sufficient level, both in-house and at our clients. In your daily work, you will therefore bridge development, RA and QA competences at Technolution and at our clients, while driving Design Control activities. Primary workplace will be in the Copenhagen area.
You will participate in:
• Planning and executing the Design Control documentation, including Risk Management, in compliance with current regulatory standards for medical device development.
• Participate in integrating Risk Management and Usability Engineering activities.
• Identification and analysis of risks and defining mitigations in cooperation with development teams.
• Continuous improvement and optimization of Technolution’s Design Control procedures and templates in collaboration with the Technolution team.
You have experience with development of medical devices and Design Control. You are outgoing, open minded, an excellent communicator, well structured, analytical and proactive. The role as Design Control Specialist requires that you are systematic and able to work efficiently alone and in groups.
Some of your qualifications:
• Good understanding of and experience with Design Control, ISO 13485, ISO 14971, IEC 62366-1 and possibly with FDA requirements for development of medical devices.
• Hands-on design control experience including the creation of requirements, test plans, test protocols and test reports.
• Hands-on risk management experience.
• As a person, you see opportunities, have great interpersonal skills and a structured approach to your work, take responsibility and meet deadlines.
• You are fluent in Danish and English.
• Relevant education on bachelor or masters level and/or relevant training.
WHAT WE OFFER
When working at Technolution, you will have extensive contact with elite Danish MedTech companies, across industry segments and disciplines, and you will be a part of a company where professionalism and unity are keywords and where initiatives are welcomed and appreciated. We have regular events of both professional and social character and strive to create a safe, trusting and developing culture. We take pride in our unpretentious and professional company environment where we know each other well and are good at making room for the individual and sees the strength in being there for each other. We are always open to be inspired by your contribution and you will have plenty of opportunities to contribute to the continuous improvement of Technolution. We offer attractive working conditions both practically, professionally, socially and economically.
Click here to learn more about Technolution.
WE LOOK FORWARD TO HEARING FROM YOU
Please send your application and CV to Michael T. Mikkelsen, Senior Partner / Project Manager email@example.com
or call regarding questions (+45) 4526 1000. Applications will be handled continuously (all applications will be stored for 6 months and then deleted).
Technolution is a fast-growing Medical Device consultancy with an ambitious growth strategy. We help our clients throughout the entire development process according to our ISO 13485:2016 certification. Technolution focuses on the Pharma, IVD and Medical Device industry both in Denmark and globally. We have room for individuality, a flat organization structure and expect everybody to take responsibility. Our office in Hørsholm is large with bright rooms, great facilities, prototype workshop and Test Lab. Drop by for a cup of coffee, and we will see if we can give your career a boost