Medical Engineer

PLEASE READ THIS.We would appreciate it if you would please take 5 minutes to complete this survey:Candidates who proactively do this will be considered first.Company Overview:Vaporox is a Denver-based medical device company pioneering a groundbreaking solution for chronic wounds. Chronic wounds are a significant and costly healthcare challenge, often reducing quality of life and leading to severe complications such as amputations or even death. Vaporox's technology addresses this urgent need, offering hope for improved patient outcomes while reducing billions in healthcare costs.In multiple clinical studies, Vaporox has been shown to heal more than 82% of chronic wounds. Vaporox's sales model is proven and highly adaptable because it competes directly with standard wound care, not other advanced treatments. Because there are no adoption risks for the customer and Vaporox delivers market-leading healing results, demand is high for our second-generation "VHT-200" device, which was FDA-cleared in March of 2023.The company has a strong intellectual property position, including 14 patents (10 issued and 4 pending).Our executives have medical and startup experience, and our advisors are deeply experienced in manufacturing and reimbursement. Our Medical Director is the former President of the Colorado Foot & Ankle Society and is on the American Board of Foot & Ankle Surgery Board of Directors.Job Description: In this role, you will work closely with the CTO, performing tests and experiments to determine our device's reliability. Must have experience in medical device product development, software development, and unit testing methods, as well as work in quality and compliance systems. You must also be familiar with assembly and disassembly of electro-mechanical assemblies. An ideal candidate possesses extreme attention to detail, strong written and communication skills, teamwork, and time management. Project management and self-direction are essential parts of daily activities.Compensation: Job Type: Full-timeSalary:$ 100,000 - $150,000Responsibilities:Responsible for project compliance to the company quality systemDesign and execute Verification and Validation activities both internally and externally for electro-mechanical systemsEvaluate contract manufacturing processes and work on process controlsOrganize test labs and perform experiments, including (but not limited to) writing test protocols, determining sample size, statistically analyzing results, and writing final test reportsExperience in preparing for and managing company activities for FDA-type auditsCoordinate customer validation activities for final product acceptanceAvailable to conduct field evaluations of customer issues - going onsite to evaluate when product issues are not reproducible in the labCloud data collection and evaluation for IoT-based applicationsManage verification and validation work for both internal and external suppliersProject management activities related to scheduling and coordinating multiple contractorsEvaluate product returns for root cause analysis and possible solutionsWork with external vendors and consultants to ensure their compliance with the QMS Create training materials for all applicable standardsExperience with Software development and associated unit testing methods for ensuring system software V&VCloud data collection and evaluation for data integrity and reliabilityFamiliar with assembly and disassembly of electro-mechanical assemblies, comfortable with basic programming functions at the PCA level of devicesExpected to completely understand all medical device development and sustaining activities related to Class 1, 2, or 3 devicesExperience in solid modeling concepts, SolidWorks software platform preferableExperience with design requirement databases and product traceabilityBonus skill set includes Quality and Regulatory experience in:Sustain, manage, and train work associates on the Vaporox quality management system (QMS)To ensure compliance, perform weekly, monthly, quarterly, and annual internal auditsCreate, modify, and maintain DHF / DHR / DMR files for product developmentCreate, modify, and maintain manufacturing policies and proceduresPhysical Requirements:An employee must meet the physical demands described here to perform the essential functions of this job successfully. While performing the duties of this job, the employee is regularly required to sit, use hands to handle or feel, and talk or hear. The employee is frequently required to walk and reach with hands and arms. The employee is occasionally required to stand, climb, balance, stoop, kneel, crouch, or crawl.The employee should be able to lift and/or move up to 50 pounds (what our device weighs). Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.Working Conditions:The work environment characteristics described here represent those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually low to moderate.Ability to travel on a limited basis to evaluate field failures or quality issues at manufacturing facilities.Equal Opportunity Employer:Vaporox is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, ancestry, religion, orientation, age, sex, marital status, national origin, disability, genetic information, handicap, or veteran status.Intangible Benefits:The satisfaction of driving real change in the industry and people's livesA diverse global community of people who are driven by a shared purpose to help patientsA business that acts with integrity in all interactions with co-workers, leaders, and customersWe value others and build success by appreciating differences in thought, opinion, background, skills, and perspectivesAn environment of continuous learning and developmentFlat organizational structures that elevate employees' level of responsibilityMeaningful opportunities for professional development and mentoringBenefits:Health InsuranceDental InsuranceVision InsuranceDisability InsuranceLife InsuranceFlexible schedulePaid time offExperience level:5-10 years of experienceSchedule:Monday to FridayWork setting:Office with work from home one day per weekAbility to commute/relocate:Lone Tree, CO 80124: Reliably commute or planning to relocate before starting work (Required)Experience:Bachelor's degree in, or other related fieldLicense/Certification:Driver's License (Required)

Created: 2025-01-16