KKR Consulting · 6 hours ago
Mechanical Engineer
KKR Consulting is seeking a motivated Junior Mechanical Engineer to join their Medical Device Engineering team. The successful candidate will support the design, development, testing, and documentation of medical devices in compliance with regulatory and quality standards.
Responsibilities
Assist in the design and development of mechanical components and assemblies for medical devices
Create and update 3D CAD models, drawings, and specifications
Support prototype fabrication, assembly, and testing activities
Perform basic mechanical analysis (tolerance, stress, thermal, or material selection) under guidance
Participate in design reviews, risk analyses, and failure investigations
Support verification and validation (V&V) testing per design requirements
Prepare and maintain technical documentation in compliance with FDA, ISO 13485, and company quality systems
Collaborate with cross-functional teams including electrical, software, quality, manufacturing, and regulatory affairs
Assist with design changes, engineering change orders (ECOs), and continuous improvement initiatives
Support transfer of designs to manufacturing and resolve production issues
Qualification
Required
Bachelor's degree in Mechanical Engineering or a related field
0–2 years of experience (internships or co-ops in medical devices or regulated industries preferred)
Basic knowledge of mechanical design principles, materials, and manufacturing processes
Experience with CAD software (SolidWorks, Creo, or similar)
Familiarity with engineering drawings and GD&T is a plus
Understanding of medical device regulations and quality systems is desirable
Strong analytical, problem-solving, and documentation skills
Ability to work effectively in a team-oriented environment
Preferred
Exposure to ISO 13485, FDA 21 CFR Part 820, or other regulated environments
Experience with prototyping, machining, injection molding, or additive manufacturing
Basic knowledge of FMEA, risk management, and design controls
Hands-on lab or manufacturing support experience
Company
KKR Consulting
At KKR Consulting, we collaborate with businesses across a wide range of industries to tackle complex challenges, fuel sustainable growth, and connect them with exceptional talent.
Funding
Current Stage
Early StageCompany data provided by crunchbase