Lead risk engineer must have ability to complete complex planning of detailed product risk management objectives and be responsible for Safety Risk Management Process for IVD products. Performs complex review of product to determine that products perform in the intended manner. Responsible for improving and conforming to latest risk management standards. In-depth design knowledge of IVD or MDD products and the compliance landscape. Will be responsible for new IVDR requirements. This position reports directly to Sr. Mgr, Engineering, Siemens Healthcare Diagnostics Inc.
Required Knowledge/Skills, Education, and Experience:
- FMEA, Hazard Analysis, FTA experience and training
- 8 years experience in Risk Management
- Expert knowledge of ISO 14971 and risk management in IVDD, IVDR
- Experience with multiple projects and previous experience designing products
- Demonstrated experience driving a successful Risk Management Process.
- Experience with Post-Market Surveillance
- IVD or MDD Experience desired
- Relisoft Software Experience desired
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. (Such as, biomedical engineering) Certification may be required in some areas.
- Advance degree desired
- 8+ years of successful experience in related field
- Travel may be up to 10% for this position
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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