Senior Engineer, Design Development, R&D

Role Overview

• The Sr. Design Engineer leads end-to-end development of advanced vascular access devices from early concept through commercialization and design transfer.
• This role integrates clinical insight, engineering rigor, and regulatory compliance to deliver innovative, manufacturable, and high-quality products.
• Operating within a matrixed organization, the Sr. Design Engineer partners with Technical Experts and Project Managers to ensure alignment to business objectives, timelines, and portfolio strategy while serving as a technical leader across disciplines.
• Concept Development: Translate clinical needs, market insights, and user feedback into clear user needs and design inputs.
• Design and Development: Develop detailed design and development plans, identifying deliverables, gaps, and contingencies.
• Verification, Validation & Compliance: Lead cross-functional teams in execution of robust design verification strategies.
• Design Transfer & Manufacturing: Collaborate with manufacturing to ensure robust design transfer and scalability.

Requirements

• Bachelor of Science – Engineering or equivalent technical discipline
• Preferred: Master of Science – Engineering or equivalent technical discipline
• Minimum of 10 years of previous experience in a related field (e.g., medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).
• Deep expertise in mechanical systems, fluid dynamics, and material properties as applied to vascular access and interventional devices, with the ability to apply first-principles engineering to develop and evaluate early-stage design concepts
• Ability to translate clinical workflows, user needs, and market insights into structured engineering requirements and design inputs, enabling development of innovative, patient-centric solutions
• Advanced capability in concept generation, feasibility assessment, and simulation-driven design, including development of analytical and computational models to evaluate performance, usability, and risk during early design phases
• Strong application of Design for Manufacturability (DFM), Design for Assembly (DFA), and usability/ergonomic principles from concept through development to ensure scalable and robust product designs
• Demonstrated expertise in early-stage risk identification and mitigation, including application of DFMEA, UFMEA, and hazard analysis to guide concept selection and design refinement
• Strong command of verification and validation methodologies, with the ability to define testable design inputs and ensure traceability from concept through validation in alignment with ISO 14971 risk management principles
• Ability to design and interpret advanced statistical analyses (e.g., DOE, tolerance analysis, feasibility data interpretation) to support concept down-selection, design optimization, and performance characterization

Tech Stack

• Assembly

Benefits

• Expected Travel: Up to 10%