Software Validation Engineer

Life Unlimited. At Smith+Neb 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.

• 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

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

Must be able to sit at a desk during normal business hours and work almost entirely on a computer while leveraging the necessary peripherals. Must be able to lift 25 lbs.

• 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, Mentorship
• Extra Perks:
  Discounts on fitness clubs, travel and more!

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. 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, generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

Smith+Neb provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.