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Fresenius Medical Care North America Design Assurance Engineer II - NxStage in Lawrence, Massachusetts

Job ID 20000DPC

Available Openings 1

Position Specific Information

We are leveraging virtual technology to engage with you and keep us all safe while you explore a career with us. We will conduct all interviews virtually, to

allow us to still connect about this job and proceed with our hiring

process while practicing social distancing.

NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals.

Position Summary:

As a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability of NxStage Medical’s equipment products.

Core Responsibilities:

  • Providetechnical and statistical reliability support to Product Development,Manufacturing and Quality organizations

  • Assistwith major efforts, or phases of projects, to resolve advanced and complextechnical and Quality-related problems

  • Contribute to New Product Introduction Projectsas a core team member and communicate activities to the extended team membersof Quality

  • Supportthe product development teams in the adoption and use of best practices,Quality tools, and Design Control methodologies

  • PerformRisk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, andFailure Mode and Effects Analysis (FMEA) activities to ensure risks areidentified and appropriately addressed

  • SupportRisk Management activities to ensure design and process shortcomings areidentified and appropriately addressed

  • Monitorand develop reliability improvements to existing & new designs

  • SupportPost Market Surveillance in the investigation of product complaints todetermine the root cause and recommend appropriate corrective and preventiveaction to prevent recurrence

  • Workwith other Groups to maintain an approved internal Quality System that meetsthe requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485

  • Evaluatequality data and prepare periodic reports to monitor trends.

  • Generate,review and approve Engineering and Development Change Orders for Design Assurance

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION :

Bachelor’s Degree in Engineering required

EXPERIENCE AND REQUIRED SKILLS:

  • 3 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience

  • ASQCertification(s) and exposure to Six Sigma techniques a plus

  • Knowledgeof Design Validation and Design Verification tools and techniques

  • Excellent verbal communication andtechnical writing skills

  • Abilityto interface with multiple groups in the organization Exposureto FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required, inparticular Design Control requirements

  • Knowledgeof risk management tools and techniques.FMEAs, FTAs, ISO 14971 risk management standard

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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