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SR. SOFTWARE DESIGN ASSURANCE ENGINEER

(Confidential)

Job Description

Position Specific Information


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. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities





Position Summary:


As a key member of the Software Design Assurance Group, the incumbent will support the activities related to the design, development, and ongoing maintenance of software-based medical device products and supporting software.



Core Responsibilities:


Provides quality oversight and guidance for software design and         development, for product and non-product software.



•Review deliverables of the development lifecycle for correctness and compliance to policies.



•Lead major efforts, or phases of projects, to resolve Software Quality-related problems



•Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed



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



•Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities



•Investigate/reproduce customer problems/issues




•Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001

Job Requirements

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.

  • Occasional travel may be required, normally less than 10%



•Bachelor's Degree in Engineering or Computer Science



•5+ years related Software Quality Assurance/Quality Engineering experience



•Working knowledge of FDA Quality System Regulation 21 CFR Part 820, General Principles of Software Validation, IEC62304, and ISO13485 required.



•Excellent verbal communication and technical writing skills



•Ability to interface with multiple groups in the organization.


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Job Snapshot

Location US-MA-Lawrence, MA
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Health Care, Pharmaceutical

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Terms & Conditions
Snapshot
(Confidential)
Company:
US-MA-Lawrence, MA
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Health Care, Pharmaceutical
Store Type:

Job Description

Position Specific Information


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. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities





Position Summary:


As a key member of the Software Design Assurance Group, the incumbent will support the activities related to the design, development, and ongoing maintenance of software-based medical device products and supporting software.



Core Responsibilities:


Provides quality oversight and guidance for software design and         development, for product and non-product software.



•Review deliverables of the development lifecycle for correctness and compliance to policies.



•Lead major efforts, or phases of projects, to resolve Software Quality-related problems



•Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed



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



•Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities



•Investigate/reproduce customer problems/issues




•Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001

Job Requirements

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.

  • Occasional travel may be required, normally less than 10%



•Bachelor's Degree in Engineering or Computer Science



•5+ years related Software Quality Assurance/Quality Engineering experience



•Working knowledge of FDA Quality System Regulation 21 CFR Part 820, General Principles of Software Validation, IEC62304, and ISO13485 required.



•Excellent verbal communication and technical writing skills



•Ability to interface with multiple groups in the organization.


SR. SOFTWARE DESIGN ASSURANCE ENGINEER Apply now