Search results for “tech”

Jobs

Senior Technical Writer (225260)

A BDN client is in need of a Technical Writer to write IFU documents for NPIs in a format that can be translated to other languages. This individual will not be doing the translation, just making sure it includes guidelines, tables, margins and is formatted in an easy to use style. IFU type documentation, service documentation (maintenance, cleaning, etc.) is needed. No graphic design experience is needed. Experience with Visio & MS Word is required for this position. Medical device experience is required, but no specific class.

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Northeast
EU MDR Risk Management & Tech File Remediation Consultant (225259)

A BDN client is looking for an experienced Medical Device contractor who has quality experience within QSR standards with direct experience in MDR Readiness regulations and MDSAP Readiness. This individual will be responsible for owning the risk management process and supporting tech file workstreams. This individual will be performing gap assessments, developing remediation plans, and then executing these remediation plans to achieve MDR compliance. In addition, this person will have understanding of EN ISO 13485, EN ISO 14971, EN 62366-1, and EN 62304, as well as have an understanding of the product life cycle for risk management including Risk Management Plans, Risk Analyses, failure modes and effects analysis (Design FMEA, Use FMEA and Process FMEA), and risk management reports.

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Midwest