Software Validation Engineer 2

Smith+Nephew•Minneapolis, MN

17h•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Software Validation Engineer will lead and support software validations that are custom developed for S+N in house or by vendor, in addition to commercial off the shelf software applications, which may be directly used for patient care, or software used by S&N's manufacturing and quality systems. This position is part of a team that may be actively involved in the product development lifecycle with regard to software validation activities, while also participating in product risk assessments, code and design reviews, and the development of software validation deliverables that are identified with in-group specifications. This role does require the engineer to be effective at working independently under limited supervision and with other engineers and departments. The Software Validation Engineer will also be responsible for following the specifications assigned to them via Training Management, whether it be in-person or electronic. Additionally, the engineer will also be required to meet annual objectives and promote continuous improvement efforts as designated by management, while supporting and emulating S+N cultural pillars.

Requirements

Bachelors degree required with a minimum 3 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing activities.
Mechanical, Chemical or Biomedical Engineering degree preferred with minimum 2 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing activities.
Must be able to 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 Haves

Working knowledge of C, C++, Python, MATLAB, SQL preferred
MCSE, ASQ yellow+, FE (EIT) certifications preferred

Responsibilities

Collaborate with other groups (written and Teams meetings) in support of software validation projects
Collaborate with other groups (written and Teams meetings) in support of regulatory submissions as needed
Review and approve software validation documentation for both medical and non-medical device software
Produce software validation packages for both medical and non-medical device software
Review and approve supplier documentation as needed
Review and approve specifications as needed
Create, update, review and approve Quality Plans as needed
Update and maintain software validation specifications as needed
Adhere to applicable regulatory requirements from multiple countries
Support and drive non-conformance reporting and mitigation efforts as needed
Support and execute CAPA mitigation efforts as needed
Ensure assigned training is completed and up to date at all times
Demonstrate proficiency with in-group specifications