Software Validation Engineer 2

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.What will you be doing?Collaborate with other groups (written and Teams meetings) in support of software validation projectsCollaborate with other groups (written and Teams meetings) in support of regulatory submissions as neededReview and approve software validation documentation for both medical and non-medical device softwareProduce software validation packages for both medical and non-medical device softwareReview and approve supplier documentation as neededReview and approve specifications as neededCreate, update, review and approve Quality Plans as neededUpdate and maintain software validation specifications as neededAdhere to applicable regulatory requirements from multiple countriesSupport and drive non-conformance reporting and mitigation efforts as neededSupport and execute CAPA mitigation efforts as neededEnsure assigned training is completed and up to date at all timesDemonstrate proficiency with in-group specificationsWhat 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 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 preferredMCSE, ASQ yellow+, FE (EIT) certifications preferredPhysical 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. Must be able to lift 25 lbs.You.Unlimited.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. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. 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.Smith+Nephew 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.Stay connected by joining our Talent Community.We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our website and learn more about our mission, our team, and the opportunities we offer.