R&D Senior Engineer

Medical Murray•Barrington Hills, IL

2d•$95,000 - $160,000•Onsite

About The Position

At Medical Murray, innovation drives everything we do. We partner with leading medical device companies to develop life-changing technologies that improve patient outcomes around the world. As a Senior R&D Engineer, you will play a critical leadership role in transforming concepts into commercially successful medical devices while guiding projects from early feasibility through production transfer. This is an exciting opportunity for an experienced engineer who thrives in a hands-on development environment, enjoys solving complex technical challenges, and wants to lead multidisciplinary teams in the development of cutting-edge catheter-based and disposable medical devices. You'll work closely with customers, project teams, manufacturing, and suppliers to bring innovative products to market on time, on budget, and with the highest level of quality.

Requirements

Bachelor's or master’s degree in biomedical engineering, mechanical engineering, or related engineering discipline required.
3+ years of medical device engineering experience required.
Experience leading technical projects and coordinating cross-functional teams.
Proficiency with SolidWorks or equivalent CAD software.
Experience with design controls, verification, validation, and risk management activities.
Strong background in product design and development for disposable medical devices.
Knowledge of materials, manufacturing processes, and prototyping techniques.
Understanding of medical device development, lifecycle and commercialization processes.
Experience supporting process development, equipment qualification, and manufacturing transfer activities.
Familiarity with FDA-regulated and ISO-compliant environments.
Strong analytical, troubleshooting, and problem-solving abilities.
Excellent verbal, written, and presentation skills.
Ability to manage multiple priorities and projects simultaneously.
Strong leadership and project management capabilities.
Ability to work independently while collaborating effectively across teams.
Proficiency with Microsoft Office applications and engineering software tools.

Nice To Haves

Experience developing disposable medical devices, catheters, or catheter-based systems preferred.

Responsibilities

Lead the design and development of disposable medical devices from concept through commercialization.
Design catheter-based delivery systems and other disposable devices using SolidWorks and rapid prototyping techniques.
Build and evaluate prototypes in a laboratory environment.
Develop innovative solutions across a variety of therapeutic areas including cardiology, neurology, and urology.
Lead design changes and continuous improvements to existing products.
Serve as the technical lead for development projects, ensuring objectives, timelines, budgets, and customer expectations are achieved.
Communicate project status, risks, and technical updates to customers and internal stakeholders.
Develop project schedules, resource plans, budgets, and technical strategies.
Participate in project quotations and feasibility assessments.
Mentor and guide engineers and technical team members throughout project execution.
Drive technical decision-making across the entire product lifecycle.
Develop feasibility, reliability, verification, and validation test plans.
Create and validate in-vitro and in-vivo models and testing methodologies.
Manage and support verification and validation activities, documentation, and reporting.
Conduct risk assessments and support design control activities including FMEA development.
Develop pilot and manufacturing processes, equipment, and procedures.
Evaluate manufacturing feasibility and support process validations and time studies.
Partner with Manufacturing Engineering to ensure successful technology transfer and production readiness.
Support manufacturing operations until projects are fully transitioned into production.
Review manufacturing document changes for impact on design intent.
Support acquisition, installation, qualification, and implementation of development and manufacturing equipment.
Create preventive maintenance procedures and support equipment maintenance activities.
Assist with equipment troubleshooting, requalification, and return-to-service activities.
Collaborate with vendors to source materials, components, and specialized processing solutions.
Follow all applicable Quality System requirements and Standard Operating Procedures.
Prepare and maintain design control documentation including project plans, design inputs, design outputs, test protocols, reports, risk analyses, and drawings.
Complete project phase deliverables and checklist requirements.
Support customer complaints and investigations as required.
Ensure compliance with regulatory and quality standards throughout the development process.