Principal Engineer | R&D

Principal Engineer | Reserach & Development Our client, a global biomedical company focused on the development and commercialization of blood management products, is currently seeking a Principal Engineer to join their team for a 6-month contract with the potential to extend.This person will serve as a lead design engineer supporting the development and life-cycle management of disposable medical devices. The role combines technical project leadership with substantial hands-on laboratory work, including prototype development, device testing, troubleshooting, test-method development, and preparation of technical reports.The engineer will independently manage project timelines and deliverables while collaborating with Project Management, Manufacturing, Quality, Regulatory, and other cross-functional partners to keep programs moving forward.Key ResponsibilitiesLead R&D activities supporting new product development, product sustaining, and life-cycle management for disposable medical devices.Serve as the lead design engineer on projects of varying size, scope, and technical complexity.Perform hands-on device testing, troubleshooting, prototype development, and fixture design.Develop clinically relevant benchtop test models and methods to evaluate device performance.Create and execute test protocols and reports supporting feasibility, design verification, and product development activities.Analyze test data using appropriate statistical methods and communicate findings to cross-functional teams and senior leadership.Manage project scope, timelines, milestones, risks, budgets, and technical deliverables.Coordinate with Project Management and cross-functional partners to ensure projects remain on schedule.Support CAPAs, supplier change notifications, design changes, and other sustaining-engineering initiatives.Manage design-control activities and Design History File deliverables in compliance with internal procedures, FDA requirements, and international regulations.Partner with Manufacturing, Quality, and Regulatory teams to support products from concept through commercialization.Create samples for manufacturing, marketing, testing, and other project needs.Prepare technical reports, project updates, and presentations for senior leadership.Support lab-equipment maintenance, preventative maintenance, calibration, and IQ/OQ activities.Participate in preclinical product testing when required.Required QualificationsBachelor’s degree in Mechanical Engineering, Manufacturing Engineering,Bioengineering, Industrial Engineering, or another relevant technical discipline.Minimum of 7 years of engineering experience within the medical device industry.Advanced CAD experience, including strong proficiency with SolidWorks.Hands-on experience with device testing, troubleshooting, prototype development, and fixture design.Working knowledge of medical device design controls and Design History File requirements.Experience developing and executing test protocols and documenting results.Familiarity with FDA Quality System requirements, GMP, QMS, and applicable international medical device regulations.Strong mechanical aptitude and practical problem-solving skills.Demonstrated ability to independently manage technical work, priorities, timelines, and project deliverables.Strong written, verbal, and presentation skills with the ability to communicate effectively across multiple functions and levels of an organization.Preferred BackgroundExperience designing, developing, or testing cardiovascular catheter delivery systems, vascular closure products, or comparable disposable medical devices.Experience with statistical study design and analysis, including DOE and ANOVA.Experience with IQ/OQ of laboratory equipment, preventative maintenance, and calibration.Experience supporting high-volume manufacturing environments.Experience with IDE, PMA, or Class III medical devices.Familiarity with Agile product-development practices.Experience interacting with customers or end users and translating customer needs into design requirements.Travel: Up to 20%Pay Rate: $80 - $83/hrIf you are interested in this position, please send your resume to apowell@daleyaa.com.