Design and Development - Technical Product Manager (DDTM)

Atos Medical was founded in 1986 and has today a vast international network with sales companies in the USA, UK, Germany, Spain, Portugal, Netherlands, Belgium, France, Sweden, Switzerland, Japan, Brazil and also exclusive distributors serving about 55 countries. Atos Medical started the research and development on the first voice prosthesis in 1987 under the name Provox. Throughout the years, Atos Medical has worked to develop Provox as the leading voice and pulmonary rehabilitation system on the market. At the same time, we now allocate substantial development and training resources to our activities in Ear, Nose and Throat. The head office is situated in Hörby, approximately 25 minutes travel from Lund. We are 420 employees in the group and 180 employees in Hörby (www.atosmedical.com).The DDTM is responsible for definition, development and maintenance of the product requirement profile for the complete product portfolio as manufactured by Atos Medical. The DDTM is an important interface to the new product development team where the DDTM is responsible for requirement assessment, identification of applicable standards, definition and implementation of design traceability (intended use, requirement specification, design verification and validation planning and reporting). Moreover, the DDTM is responsible for implementing procedures and guidelines to facilitate regulatory compliance, customer satisfaction and continuous improvements throughout the complete product life cycle. The role requires extensive knowledge and skills in cGMP compliance and continuous improvement strategies. Preferably, the successful candidate is very familiar with ISO 14971 (Risk Management) and quality by design (QBD). Domestic and international travelling may occur.

Our products, being either voice prostheses or disposable products, are made of medical grade silicone, polymers or metals and are often patent-protected.


Candidate Profile
• Academic degree, preferably Master, in applied physics, mechanical engineering or similar
• Proven experience of new product development within the medical device industry
• Proven knowledge of cGMP
• Proven knowledge of medical device manufacturing, including applicable regulations (QSR, MDD, JPAL, CMDCAS etc.)
• Proven leadership qualities
• Excellent communication skills in Swedish and English (spoken and written)
• Knowledge of Risk Management in accordance with ISO 14971 and associated methods for risk analysis (FMECA, FTA)

If you would like to have further information, please contact Design Controls Manager Mikael Sundberg, mikael.sundberg@atosmedical.com.