Lab Technician II

Job Title: Lab Technician II

Location: Boulder, CO
Duration: 12+months (Possibility of extension)

JOB ROLE

·The candidate will support the Post Market Vigilance Analytics and Investigations team's activities for the Surgical Solutions Division.

·These activities include; performing failure analysis on clinically applied medical device customer returns to ensure high levels of quality, reliability, safety, and efficacy, MDR (Medical Device Reporting) /AE (Adverse Event) reporting, a review of the FDA MAUDE database for complaints involving Healthcare Surgical Solutions products, and assisting in implementing Continuous Improvements identified through Lean/Six Sigma tools.

·Continuous Improvement projects will entail Standard Work Instructions, and Gauge Repeatability & Reproducibility studies.

·Additional responsibilities include management of clinically applied medical device retains and associated paper records in accordance with Healthcare Record Retention Policies and support staffing needs.

ESSENTIAL FUNCTIONS
The following functions will be performed under direct supervision;

·Test and thoroughly evaluate rudimentary surgical devices to determine root cause analysis
Identifying the appropriate visual and functional test method/regiment from existing Standard Operating Procedures for complaint product evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination.

·Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards

·Replicate reported failure mode with bench top or in vivo test methods and document observations accordingly

·Initiate and distribute Corrective Action Requests to Manufacturing or Engineering Departments as needed

·Prepare technical investigation reports based on results of evaluation and/or review of the manufacturing plant reports to be documented in the complaint database and incorporated into customer response letters

·Assist in the coordination of sanitization of clinically applied medical device returns and shipment to respective Healthcare Manufacturing facilities

·Certification with OSHA's BloodBorne Pathogens Standard 29 CFR 1910.1030

·Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations

REQUIREMENTS:

·Must be available to work at least 40 hours a week

·Experience in a laboratory environment and with laboratory equipment or

·Academic knowledge in scientific research methods

·Experience with medical devices preferred but not required

·Knowledge of quality control concepts desirable

·Must be proficient with MS Office (with emphasis on Excel and PowerPoint)

·Experience writing and reading code (C++) preferred but not required

·Must have knowledge in using electronic/electrical tools

·Time management skills

·Critical independent thinking and timely follow up

·Excellent written and verbal skills necessary to include technical writing

EDUCATION
• High School Diploma required
• BS Degree in a technical curriculum or equivalent industry experience preferred

WORKING CONDITIONS/PHYSICAL ACTIVITIES

·Time will be spent equally in an office setting and a Biohazardous laboratory environment requiring use of personal protective equipment in accordance with CDC and OSHA regulations

·Lab Environment: Required to perform laboratory activities within a biohazard laboratory setting requiring the use of personal protective equipment.

·Frequent sitting, walking, standing and occasional kneeling, crouching, crawling, balancing, stooping climbing required.

·Frequent use of eye, hand and finger coordination in laboratory investigations and use of equipment will be necessary.

·Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone is required.

·Physical effort required by handling objects up to 20 pounds