Smith+Nephew
Medical Devices
SoftwareValidationEngineer2
“Software Validation Engineer 2 at Smith+Nephew. Skills: Software validation, Validation documentation, Regulatory requirements, Testing. Lead and support software validations. Participate in product risk assessments”
What You'll Achieve.
Meet annual objectives
Industry & Context.
Must be able to sit at a desk, Work almost entirely on a computer, Able to lift 25 lbs
What They're Looking For.
Must Have
Bachelors degree, minimum 3 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing activities, communicate effectively both verbally and in written form, build productive relationships, demonstrate effective project and time management, proficiency using PC Applications including but not limited to Microsoft Word, PowerPoint and Excel
Nice to Have
Mechanical, Chemical or Biomedical Engineering degree, minimum 2 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing activities, Working knowledge of C, C++, Python, MATLAB, SQL, MCSE, ASQ yellow+, FE (EIT) certifications
What You'll Do.
Lead and support software validations
Participate in product risk assessments
Participate in code and design reviews
Develop software validation deliverables
Follow assigned specifications
Meet annual objectives
Promote continuous improvement
Collaborate with other groups
Review and approve software validation documentation
Produce software validation packages
Review and approve supplier documentation
Review and approve specifications
review and approve Quality Plans
Update and maintain software validation specifications
Adhere to applicable regulatory requirements
Support and drive non-conformance reporting
Support and execute CAPA mitigation efforts
Ensure assigned training is completed
How You'll Work.
Team & Collaboration
Collaborate with other groups (written and Teams meetings); Work with other engineers and departments
Communication Scope
Communicate effectively both verbally and in written form
Process & Methodology
Effective project management
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