Design Assurance Engineer II - NxStage

Profile

Job ID 21000MBIAvailable Openings 1PURPOSE AND SCOPE: 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. PRINCIPAL DUTIES AND RESPONSIBILITIES: Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations Assist with major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed Monitor and develop reliability improvements to existing & new designs Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485 Evaluate quality data and prepare periodic reports to monitor trends. Generate, review and approve Engineering and Development Change Orders for Design Assurance Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. 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 ASQ Certification(s) and exposure to Six Sigma techniques a plus Knowledge of Design Validation and Design Verification tools and techniques Excellent verbal communication and technical writing skills Ability to interface with multiple groups in the organization Exposure to FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required, in particular Design Control requirements Knowledge of 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.,identifier:21000MBI,qualifications: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 ASQ Certification(s) and exposure to Six Sigma techniques a plus Knowledge of Design Validation and Design Verification tools and techniques Excellent verbal communication and technical writing skills Ability to interface with multiple groups in the organization Exposure to FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required, in particular Design Control requirements Knowledge of 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.,title:Design Assurance Engineer II - NxStage,url:https://jobs.fmcna.com/job/lawrence/design-assurance-engineer-ii-nxstage/488/16802418528,workHours:Manufacturing,hiringOrganization:{@type:Organization,name:Fresenius Medical Care},jobLocation:{@type:Place,address:{@type:PostalAddress,addressLocality:Lawrence,addressRegion:MA,addressCountry:United States,streetAddress:,postalCode:01843}}}

Company info

Renal Advantage Inc.
Website : http://www.renaladvantage.com