Product Risk Management Engineer

Do you want to contribute to a top quallity medical research? We are searching for a candidate that wants to work for a global meditech company in Lund that touches the lives of millions of people around the world every day.

Responsibilities
Works as part of a team performing engineering work in Risk Management through application of standard engineering techniques, procedures and criteria.
• Support design teams in risk process execution using relevant methodologies, tools and techniques in the development/maintenance of Risk planning and deliverables.
• Collaborates with cross-functional resources (e.g., hardware, clinical, human factors etc.) involved in Risk Management process activities.
• Acts independently with minimal supervision. Expected to make suggestions on improvements based on recent technical knowledge.
• Manages risk-related Design History File (DHF) elements and associated documents, including the Risk Management File (RMF).
• Present and explain Risk Management File documentation and/or Baxter Product Risk Management procedure during external audits.

Your profile
• Experience with tools related to structured risk control activities, for instance Failure Mode Effects and Analysis (FMEA), Fault Tree Analysis (FTA) with support from SW like DOORS and Windchill Quality Solutions (WQS) and/or other Requirements Management & Risk tools as well as in Excel.
• Strong critical thinking skills.
• Familiarity with regulations and standards related to Risk Management: (e.g. European Medical Device Regulation 2017/745, ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601 etc.).
• Requires strong organization- and communication skills, with the ability to interface with both technical and non-technical personnel throughout the organization.
• Able to work with a cross-functional team in a fast-paced environment.
• MSc degree in Engineering required with at least 2-4 years of practical experience, preferably in Medical Devices.

About the organisation
This is a a consultant assignment at a global meditech company in Lund until 2022-12-31. During that period you will be employed by QRIOS Life Science & Engineering.
Submit your application today! If you have any questions regarding the consultant assignment feel free to contact us QRIOS.