Design Assurance Engineer
Location: Mahwah, NJ
Duration: 12 months
- Analyze post market data to identify any potential safety signals that may alter the benefit-risk assessment of product on the market
- Update Risk Management Files if necessary
- Conduct remediation activities on existing Risk Management Files to ensure compliance to ISO 14971
- Development of PSURs in preparation for the EU MDR Transition
- BS Degree in Engineering or related field of study
- 2+ years of experience as a Reliability or Quality Engineer in a regulated design environment
- Prefer experience with medical device Product Development Lifecycle, including risk management and design verification & validation
- Knowledge of FDA QSR, EU MDR, ISO 13485, Design Control Procedures and ISO 14971
Remediation,Medical Device,Analysis,Biomedical,Risk Analysis,Medical Device-Mfg/eng
Total Quality Management
Provide Technical Guidance
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Job ID: BHJOB18630_141883
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With a single-source, multi-disciplinary approach, Joulé helps scientific, clinical, and healthcare clients find talent, manage specialized equipment and increase productivity. Our clients range from small and mid-sized companies to Fortune 500 firms specializing in biotechnology, pharmaceutical, chemical, medical device, food science and healthcare services. We specialize in the following areas:
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- Scientific and clinical staffing – recruiting hard-to-find skills with extensive scientific and clinical industry experience, Joulé excels at placing top talent across core specialty areas.
- Equipment services – for calibration, maintenance, validation and more, Joulé offers comprehensive laboratory and facility support that comes with a total quality commitment backed by ISO 9001:2008 certification.
- Healthcare recruiting – Joulé is trusted source of healthcare professionals for organizations of all sizes for nearly four decades.