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.
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.
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.
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.