DFMEA and Risk Management Engineer

- Execute and support on-time completion of Risk Management Deliverables.
- Maintain existing Risk Management files throughout products lifecycle according to ISO 14971:2019 and ISO TR 24971:2020, ensuring the latest knowledge on risk is reflected in the risk documentation including gap analysis and remediation as necessary.
- Initiate and manage Risk Management deliverables (DFMEA, Risk Management Plan, Risk Analysis, Risk Management reports etc.) according to 14971:2019 and ISO TR 24971:2020.
- Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy
- Ensure verification and validation evidence supports the planned risk mitigation strategy and traceability.
- Develop, modify, apply and maintain quality standards and protocol for risk management, complying with the Medical Device Regulations (MDR), U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Collaborate with different departments across the organization to understand, review data, discuss and assess the patient/user risk/harm severity sources and estimate the probability or harm occurrence.
- Interact and build productive relationships with all levels of employees (R&D, Quality, Document control and Production), leading Risk Management activities to achieve required results and goals.
- Additional duties may be identified by functional management based on the current project/business objectives, including up to 10% travel.
- Identify and troubleshoot missing documentation or processes.
- Support DHF content completion, integrity, and regulatory & standards compliance
- Ensure the readiness of internal and/or external audits
- Manage continuous improvement projects.

- Opportunity to be part of a strong and stable international company producing medical devices
- Professional education and continuous gaining of new experience
- Travel allowance for commuting to work
- Referral bonus
- Meal vouchers €5

If you are interested in this position, please send us your CV in English language. We will carefully evaluate all applications and contact suitable candidates.