Software Validation Engineer 2

United StatesHybrid

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,

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 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 What will you need to be successful? 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
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.
Working knowledge of C, C++, Python, MATLAB, SQL preferred MCSE, ASQ yellow+, FE (EIT) certifications preferred Physical Demands: Must be able to sit at a desk during normal business hours and work almost entirely on a computer while leveraging the necessary peripherals.

Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized,
#LI The anticipated base compensation range for this position is $70,500 - $105,750 USD annually (or hourly) The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity.
Compensation decisions are dependent upon the facts and circumstances of each position and candidate.
In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

At Smith+Nephew we design and manufacture technology that takes the limits off living.
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.
It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.
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benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.