Senior Mechanical Engineer - Medical Device R&D & Design

United Pharma; Kentucky; On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma seeks an experienced Mechanical Engineer to lead design engineering for vascular closure and disposable devices. You will drive R&D from concept through commercialization, ensuring compliance with FDA, QMS, and design controls.

The role involves leading cross-functional projects, developing test methods, and advancing bench-top testing and validation. A strong background in Class III devices and IDE/PMA is highly valued.

Qualifications

• 7+ years of medical device industry experience.
• Bachelor’s degree in Mechanical, Manufacturing, Biomedical/Bioengineering, Industrial Engineering, or related field preferred.
• Strong experience in medical device design, development, testing, and troubleshooting.
• Hands-on experience with prototype development and device testing.
• Strong knowledge of Design Controls, DHF, Design Verification, and QMS requirements.
• Advanced SolidWorks/CAD and fixture design experience.
• Experience with IQ/OQ, calibration, and lab equipment maintenance.
• Cardiovascular catheter/delivery system experience is a plus.
• Experience with Class III devices, IDE, PMA, and high-volume manufacturing is preferred.

Responsibilities

• Lead R&D and product lifecycle activities, including CAPAs, SCNs, sustaining engineering, and design initiatives.
• Support new product development, design, testing, troubleshooting, and prototype development.
• Lead cross-functional projects involving R&D, Manufacturing, Quality, and Regulatory teams.
• Develop and execute test protocols, reports, verification activities, and design studies.
• Develop bench-top test methods and models for device performance evaluation.
• Support IQ/OQ, preventive maintenance, calibration, and lab equipment activities.
• Design fixtures and utilize SolidWorks/CAD for product and testing requirements.
• Identify project risks, manage critical paths, and support timely product commercialization.
• Ensure engineering activities comply with FDA, GMP, QMS, and international regulatory requirements.

Skills

Medical device experience

Design controls

Prototype development

Testing and troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

United Pharma seeks an experienced Mechanical Engineer to lead design engineering for vascular closure and disposable devices. You will drive R&D from concept through commercialization, ensuring compliance with FDA, QMS, and design controls.

The role involves leading cross-functional projects, developing test methods, and advancing bench-top testing and validation. A strong background in Class III devices and IDE/PMA is highly valued.