System Engineer/Product maintenance

Contura International A/S is looking for a System Engineer to join our product maintenance team Company description Contura International A/S (Contura) is a Copenhagen based medical technology company that develops and manufactures innovative medical products in the fields of orthopaedics, soft tissue augmentation and animal health using its unique, patented hydrogel technology. The manufacturing facility, which is approved in US, Europe, Canada, Australia, etc., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products. Contura has obtained FDA approval for its product for treating stress urinary incontinence in women, Bulkamid, and a manufacturing license (§39) for production of its hydrogel technology as a medicinal product. The company’s development, manufacturing and testing processes comply with the European Medical Devices directive 93/42/EEC and the quality system meets the standards required to obtain ISO 13485:2016. Production is performed in ISO class 8/GMP C cleanroom. Contura is currently 110 employees but is growing by the month. The company offers: A challenging position in a growing company with dedicated people and a strong pioneer spirit. We reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment. There is a natural focus on the ongoing development of professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry. The position: The position will entail understanding and taking care of our hydrogel technology platform as well as relevant documentation and working diligently to ensure regulatory and quality requirements. The focus will be to keep the product documentation up to date. You will be working alongside a larger group of process supporters/engineers who are well versed in the day-to-day flow of production. The tone in the team is informal, but we all take pride in our work and aim to work in an efficient manner to meet agreed deadlines. We like to celebrate our achievements with a glass of champagne, a slice of cake or an ice cream. Your main responsibility as a system engineer will be, but is not limited to: Ensure up to date documentation, e.g. DHF, DMR, risk assessment, etc. Facilitate necessary test required to maintain the level of documentation, e.g. design output testing, stability studies, etc. Assist on development projects of new products Assist on digitalization projects of relevant documentation Work in close collaboration with operations team Work in close collaboration with QA and RA to meet needed requirements Professional profile/qualifications Engineer, chemist, pharmacist, microbiologist or other relevant higher education within natural science Medical device industry experience preferred Strong decision-making skills Enjoys problem solving Knowledge of statistical techniques preferred Basic knowledge of polymer chemistry is an advantage Strong team player Fluent in English (oral and writing) Personal Profile As a person you are service minded, and a team player. You thrive in an environment with sharp deadlines and take pride in delivering a solid performance and on-time results. You are analytical and enjoy problem solving and can think out-of-the-box. The ideal candidate would have 3-5 years of experience within the field, but as more positions are open this not a strict requirement. A background from the Medical Device- or Pharma industry would be beneficial. You handle multiple tasks, and you meet agreed deadlines. You are open-minded and enjoy teamwork with colleagues from other departments. You have an eye for detail, are analytical and take independent responsibility for carrying out daily tasks. Your approach to your work is structured and "hands on". Application Send your application and your CV via the apply button no later than 30-04-2025. For further information contact Dines Bennetsen, (Operations Manager) at dines.bennetsen@contura.com or Birgitta Nielsen (Head of Human Resources) at birgitta.nielsen@contura.com. Job interviews may be conducted prior to the application deadline. For more information about the company, please visit www.contura.com, www.bulkamid.com and www.arthrosamid.com.Apply with QuickApply on Jobindex.