Engineer I, Quality Sterilization

Supports sterilization, environmental and product monitoring programs.  Plans and directs activities concerned with design, development, application, validation, implementation and maintenance of quality standards to ensure new and existing products meet requirements for sterilization, microbiology and biological safety.

Essential Duties and Responsibilities

• Sterilization Cycle Validations:
• Assists in the planning and maintenance of cycle/process validations in approved or proposed sterilizer equipment
• Product Adoptions:
• Responsible for planning, writing, and advising on Sterilization Evaluations and Qualifications for new or changed products.  
• Sterilization Routine Processing:
• Support day to day sterilization opertations including process document review, contractor and laboratory communications, mitigation of process deviations.
• Biological Safety:
• Responsible for planning and writing Biocompatibility Assessments and Reports to evaluate new or changed products.
• Product Monitoring:
• Assists in scope, planning, and maintenance of Product Bioburden and Bacterial Endotoxin monitoring programs.
• Environmental Monitoring:
• Assists in scope, planning and maintenance of Environmental monitoring programs.
• Serves as a plant resource for:
• Consultant in interpretation of ISO/FDA/AAMI regulations related to sterilization, environmental monitoring, and/or biological safety.
• Procedure generation/modification.
• May perform other duties as assigned

Supervisory Responsibilities

No

Regulatory Responsibilities

• Manages in order to ensure compliance with all relevant regulatory/legal requirements

Management

Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure all employees are trained to do their work and their training is documented

Education and Experience

• Bachelor's Level of Degree in the Biological Sciences or Engineering field of study
• Equivalent work related experience acceptable in lieu of degree: No
• 0-3 years of demonstrated experience in scientific discipline with an emphasis on chemistry, microbiology, biology, or biomedical sciences.
• No Certifications Required
• Any preferred education, experience or certifications:  Knowledge of biocompatibility of materials preferred

Skills/Knowledge

• Familiarity with regulations and standards published by FDA, USP, HIMA, AAMI, ANSI, ASTM, and ISO.
• Knowledge of probability and statistics, experimental design methods.
• Technical writing and oral communication skills.
• Working knowledge of computers, spreadsheets, databases, and statistical programs.

• Proficient in the following computer software applications: Microsoft Office
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
• Exposure to (insert any extreme climate and/or work conditions)  standard office environment
• Ability to frequently lift and/or move up to 15 lbs.
• Ability to occasionally lift and/or move up to 50 lbs.
• Ability to regularly sit or stand for extended periods of time .

• This position requires some travel up to 10% of the time