Mechanical Engineer

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

We are seeking experienced Mechanical Engineers to support medical device product development and R&D within a vascular closure/disposable devices environment. The role will lead design engineering activities from concept through commercialization while ensuring compliance with FDA, QMS, and internal design control requirements.

Key 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.

Required Qualifications:

• 7+ years of medical device industry experience.
• Bachelor’s degree in Mechanical, Manufacturing, Biomedical/Bioengineering, Industrial Engineering, or related technical 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.