Sterility Assurance Engineer II

Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

ESSENTIAL FUNCTIONS

PERFORMED

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations, including annual requalification’s and dose audits as necessary.
• Monitors the environmental monitoring program for the cleanrooms.
• Performs and documents product adoptions into existing EO sterilization cycles using the appropriate standards.
• Communicates and interfaces with contract sterilizers and laboratories.
• Works independently on standard projects while assistance is furnished on unusual problems.
• Receives guidance on specific assignment objectives, complex features, and possible solutions.
• May supervise the work of technicians in the team.
• Completes investigation and disposition of complex NC’s as applicable.
• Manages compliance to Sterility Assurance and Environmental metrics including NC timeliness.
• Works on special projects, writes ECN's, and leads continuous improvement activity.
• Oversees Environmental Monitoring programs for cleanrooms.
• Supports both internal and external audits.
• Performs other duties and tasks as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- up to 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Vision
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral SUMMARY OF MINIMUM QUALIFICATIONS
• Education and/or experience equivalent to a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience.
• Ability to apply analytical skills and scientific technical principles in problem solving and development.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
• Strong interpersonal and organizational skills and the ability to work effectively as a team member.
• Working knowledge of international standards as applicable to the department.
• Scientific techniques/evaluation/selection/application COMPETENCIES
• Plans/surveys/structures/equipment
• Special projects/ECN's/prototype creation
• NCMR causes/corrective actions/dispositions
• Leadership COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure. As an eligible Merit employee, you can expect the following: * Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights * Medical/Dental & Other Insurances (eligible the first of month after 30 days) * Low Cost Onsite Medical Clinic * Two (2) Onsite Cafeterias * Employee Garden | Gardening Classes * 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays * 401K | Health Savings Account To see more on our culture, go to www.merit.com/careers . Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.