Requistion ID : 77862

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Software Development Process Manager (m/f/d) for SaMD

Are you passionate about developing innovative medical technology while ensuring the highest quality and regulatory compliance? We are seeking a Software Development Process Manager (m/f/d) for SaMD to join our dynamic Software R&D team in Zurich (CH) or Bensheim (DE). You will play a key role in both streamlining our development processes and ensuring our SaMD products meet all regulatory requirements. This position requires a strong understanding of agile methodologies and relevant regulations like MDR and FDA. Join us and make a real difference in dental care of the future!

Key Responsibilities:

• Work within R&D on processes for new product developments and maintaining existing SaMD (Software as Medical Device) products

• Structure and automate our software development process to comply with regulatory requirements regarding quality, documentation, and tracebility (Design Control, DC)

• Continuously improve our agile software development processes

• Support our transition to a continious compliant release process of SaMD

• Support the Quality Control Manager to ensure quality and regulatory compliance of the software design and development toolchain and processes

• Support quality related processes, e.g. internal audits, supplier audits, external audits, CAPA management, training, etc.

   

   

Requirements and Qualification:

• Bachelor or master's in engineering, computer science, life science or other related fields. Software background is a plus

• Minimum of 5 years professional experience in new product development of SaMD; experience in quality management or regulatory affairs of medical devices in a software environment

• Good technical understanding of software and agile software development process

• Experience with creating deliverables according to IEC 62304, MDR and FDA Guidance

• Knowledge of MDR, CFR FDA, MDSAP, ISO 14971, ISO 13485, IEC 62304 is beneficial

• Excellent communication and team player skills

• Independent and results-oriented way of working

• Fluency in English (written and spoken) – German is a plus