Engineer, Senior DEV
Medical Murray
Summary
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. 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.
Job description
Overview
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. 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.
Product Development & Design
- 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.
Project Leadership
- 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.
Verification, Validation & Testing
- 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.
Manufacturing & Process 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.
Equipment & Technical Support
- 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.
Quality & Compliance
- 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.
Requirements
- Bachelor's or master's degree in biomedical engineering, mechanical engineering, or related engineering discipline required
- 5+ years of medical device engineering experience required
- Experience developing disposable medical devices, catheters, or catheter-based systems preferred
- 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
Benefits
- Medical, Dental & Vision
- Company-paid Life Insurance
- Short & Long-Term Disability
- HSA-eligible Plans
- 401(k) Safe Harbor
- 18 Days PTO
- TeleDoc Access
- Identity Protection
- Tuition Reimbursement
- Voluntary Life Insurance
- Community Volunteering PTO
Company overview
Medical Murray is a privately-owned contract development and manufacturing organization (CDMO) specializing in the design, development, and production of complex medical devices for minimally invasive procedures. Founded in 1996 and headquartered in North Barrington, Illinois, the company has established itself as a leading provider of innovative catheter systems, permanent implants, and bioabsorbable devices for vascular, urology, and surgical applications. With ISO 13485:2016 certification and FDA-registered facilities across multiple locations in Illinois and North Carolina, Medical Murray offers comprehensive services ranging from initial concept development and prototyping to full-scale manufacturing, assembly, packaging, and sterilization. The company's expertise includes complex catheter systems, delivery systems, steerable devices, balloon catheters, covered stents, and advanced material technologies including nitinol, ePTFE, and bioabsorbable polymers. Serving clients from startups to large OEMs, Medical Murray operates Class 7 certified cleanrooms and maintains an ISO/IEC 17025:2017 accredited testing laboratory for rigorous device validation. The company's collaborative approach and technical proficiency have made it a trusted partner in bringing innovative medical devices to market across cardiovascular, neurovascular, orthopedic, gastroenterology, and urology markets.