Lab Technician II

Position Overview

Job Title: Lab Technician II
Location: Boulder, CO
Duration: 12+ months (Possibility of extension)

Integrated Resources, Inc – a premier staffing firm – is seeking a Lab Technician II to support the Post Market Vigilance Analytics and Investigations team for the Surgical Solutions Division. This role involves performing failure analyses on clinically applied medical device customer returns, reporting under MDR (Medical Device Reporting)/AE (Adverse Event), reviewing the FDA MAUDE database, and assisting in Continuous Improvement projects through Lean/Six Sigma tools.

Key Responsibilities

• Perform failure analysis on surgical devices to determine root cause and ensure high levels of quality, reliability, safety, and efficacy.
• Identify and execute appropriate visual and functional testing methods per Standard Operating Procedures, including dimensional and/or tensile testing.
• Replicate reported failure modes using bench top or in vivo test methods and document observations for definitive analysis.
• Initiate and distribute Corrective Action Requests to Manufacturing or Engineering Departments as needed.
• Prepare technical investigation reports and manage clinically applied medical device records in accordance with Healthcare Record Retention Policies.
• Ensure compliance with FDA, USP/EP/ASTM standards, OSHA's BloodBorne Pathogens Standard, and other international regulatory requirements.

Required Qualifications

• Availability to work at least 40 hours per week with experience in a laboratory environment or solid academic background in scientific research methods.
• Proficient in using laboratory equipment and MS Office applications (especially Excel and PowerPoint) with strong technical writing skills.
• Certification with OSHA's BloodBorne Pathogens Standard (29 CFR 1910.1030) and familiarity with quality control concepts.
• Must have knowledge in using electronic/electrical tools with effective time management and independent critical thinking skills.
• Educational Requirement: High School Diploma required; BS Degree in a technical curriculum or equivalent industry experience is preferred.

Preferred Qualifications

• Experience with medical devices and familiarity with Continuous Improvement methodologies such as Lean/Six Sigma.
• Experience in writing and reading code (C++) is a plus.
• Prior exposure to technical investigations in a regulated environment.

Benefits & Perks

• Referral Bonus: $500 per candidate for successful referrals.