Sterility Assurance Engineer II

Merit Medical Systems; Tijuana; Hybrid; MXN 360,000 - 480,000; Full time

Job summary

Merit Medical in Tijuana, Mexico, is seeking a Sterility Assurance Engineer II to lead sterilization validations, monitor cleanroom environments, and drive continuous improvement initiatives. You will coordinate with contract labs and sterilizers, supervise technicians, and respond to NC investigations while ensuring compliance with international standards.

Ideal candidates have a Bachelor's in Engineering or related field with several years of experience in sterility assurance and ECN

Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or technical field with five years related experience.
• Apply analytical skills and scientific principles to problem solving and development.
• Proficient computer skills including spreadsheets, word processing, and databases.
• Strong interpersonal and organizational skills and the ability to work in a team.
• Working knowledge of international standards applicable to the department.
• Knowledge of scientific techniques and evaluation methods.

Responsibilities

• Writes sterilization validation protocols and final reports.
• Coordinates and executes sterilization validations, including annual requalifications and dose audits.
• Monitors the environmental monitoring program for cleanrooms.
• Documents product adoptions into EO sterilization cycles using standard methods.
• Interacts with contract sterilizers and laboratories.
• May supervise technicians and oversee NC investigations and dispositions.
• Supports audits and continuous improvement projects.

Skills

Sterility Assurance

Validation

Environmental Monitoring

Problem Solving

Team Leadership

Education

Bachelor's Degree in Engineering or Technical Field

Tools

MS Excel

MS Word

Database Software

ECN Management

Job description

## Sterility Assurance Engineer IIApply: Onsite: Tijuana, Mexico: Full time: Posted Today: JR117799**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 AccountTo see more on our culture, go to www.merit.com/careers.Military Veterans are encouraged to Apply.