Summary from listing
Coloplast is hiring Systems Engineers to support product development for intimate healthcare products. The role drives design control and product risk management, translates requirements with end-to-end traceability, maintains systems engineering documentation, supports verification and validation, participates in design reviews and change control, and ensures compliance with regulatory and quality requirements such as MDR, FDA, ISO 13485, and ISO 14971. The position requires a degree in engineering or a similar technical discipline, experience with systems engineering and design control in a regulated environment, knowledge of risk management and requirements engineering, and cross-functional collaboration experience; medical-device experience and Polarion experience are advantageous. One permanent position and one 12-month maternity-cover position are available.
