Icon hamburger
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.

Design Assurance Engineer

Joule Mahwah Full-Time
Apply Now

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

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
Apply to this job.
Think you're the perfect candidate?
Apply Now

Job ID: BHJOB18630_141883


For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.

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:

  • 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.

View the full profile