Hiring: R&D Engineer II Company: Laborie Location: Maple Grove, MN Job Posted Time: 2026-09-16 13:48:41 Employment Type: Contract Target Skills & Keywords : AutoCAD, CAD, Product Lifecycle Management, R, Risk Management, Root Cause Analysis, Six Sigma, SolidWorks About the job Experience: •5+ years' experience as a R&D or Sustaining Engineer preferably in Medical Devices or other regulated FDA/QSR and ISO environment •7+ years’ experience as a R&D Engineer in a n Required Skills: •Lead and oversee activities on new product development and product/process improvement for consumable medical devices (Class I, II, and II) including design, prototyping, material selection, verification and validation, maintaining DHF documentation, and design for manufacturability/manufacturing transfer. •Develop product test methods by studying product requirements; research, design, modify •, and test medical devices including combination products. •Partner cross-functionally with manufacturing to identify and qualify equipment vendors. •Plan, document, and execute design verification and validations. IQ/OQ/PQ, draft protocol/reports, risk management ( •Develop applicable manufacturing documents including MPs, IPs, LHRs, and material handling procedures. •Prepare, review, and approve processes, protocols, reports, and other controlled documentation. •Ensure processes and procedures comply with relevant regulations such as EU MDR, ISO, FDA, etc. Qualifications: •BS degree in Biomedical, Mechanical, Chemical Engineering or related with 7+ years’ experience as a R&D Engineer in a n •Strong knowledge of injection molding and assembled consumable medical device technologies, processes, and associated requirements and/or experience designing catheters, associated manufacturing processes, and interfacing with contract manufacturers. •Proven experience and knowledge of design controls, device design and development standards, FDA regulation, GMP practices and QSR requirements •Proven experience in the end-to-end development cycle, preferably with exposure to both small and large companies •Trained in and uses Design •For Six Sigma, Lean Six Sigma, DFM/A and GD&T principles to optimize product development. •Leading successful product launches and regulatory submissions Compensation: •Paid time off and paid volunteer time Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!