Job Description
Expected Travel : Up to 10% Requisition ID : 13833 About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. Position Summary The Design Quality Assurance (DQA) Engineer is responsible for ensuring that product design and development activities comply with applicable regulatory and quality requirements, including ISO 13485, EU MDR (2017/745), MDSAP, and FDA 21 CFR Part 820 (QSR). This role partners closely with R&D, Manufacturing, Regulatory Affairs, and Program Management to ensure design control compliance, effective risk management, and successful product development from concept through commercialization. Principal Responsibilities • Ensure compliance with Design Controls (21 CFR 820.30) and ISO 13485 design and development requirements. Provide quality oversight for design and development activities throughout the product lifecycle. Participate in and approve design reviews, ensuring deliverables meet regulatory and internal quality standards. Ensure completeness and compliance of Design History Files (DHF). Lead and support design control deliverables, including: Design and development plans, Design inputs and outputs, Design verification and validation (DV&V), Design transfer. Ensure robust traceability matrices linking user needs, design inputs, outputs, verification, and validation. Facilitate and review risk management activities in accordance with ISO 14971: Hazard analysis, Risk assessments and mitigations, Risk-benefit analysis. Review and approve design verification and validation protocols and reports. Ensure test methods are scientifically sound and compliant with regulatory expectations. Evaluate statistical justifications for sample sizes and acceptance criteria. Ensure alignment of validation activities with intended use and user needs. Ensure appropriate design change control processes are followed, including re-verification/re-validation as required. Assess impact of changes on regulatory submissions and product risk. Ensure smooth design transfer to manufacturing with complete and compliant documentation. Review Device Master Record (DMR) elements for accuracy and completeness. Partner with Manufacturing and Process Engineering on validation strategies (IQ/OQ/PQ alignment with design intent). Support internal and external audits (FDA, Notified Body, MDSAP) related to design controls. Act as SME for design quality systems during inspections. Analyze design-related quality metrics (e.g., complaints, CAPAs, field issues). Support CAPA investigations related to design deficiencies. Education / Experience Requirements • Bachelor’s degree in Engineering or related technical field (Mechanical, Biomedical, Electrical, etc.). Minimum 2–5 years of experience in medical device quality or design assurance. Knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR, MDSAP, ISO 14971. Specialized Skills / Other Requirements • Experience supporting Class II/III medical devices. Direct involvement in FDA inspections, Notified Body audits, o