Senior Mechanical Engineer – Medical Devices R&D & Production

LKC Technologies, Inc.; Indiana; On-site; USD 110,000 - 150,000; Full time

Job summary

LKC Technologies, Inc. seeks an experienced Senior Mechanical Engineer to join its R&D team in Germantown, MD. This onsite role focuses on medical devices through concept to manufacturing transfer, emphasizing design, validation, and product commercialization.

You will work with cross-functional teams and external suppliers to develop injection-molded components, electromechanical systems, and regulatory-compliant documentation for patient care devices.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 8+ years of product development experience in medical devices.
• Experience with injection-m molded plastic components and tooling.
• Experience with mold qualification and validation activities (IQ, OQ, PQ).
• Strong understanding of medical device design controls and regulated product development.
• SolidWorks proficiency for 3D modeling and drawings.

Responsibilities

• Guide development and qualification of new injection molds and molded components.
• Coordinate mold design reviews, tooling acceptance activities, and first article inspections.
• Partner with Quality to develop and execute mold validation activities.
• Support design transfer and manufacturing implementation activities.
• Create and maintain design documentation per quality/regulatory standards.

Skills

Cross-functional collaboration

Problem solving

Communication

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Mold tooling & qualification

Job description

LKC Technologies, Inc. seeks an experienced Senior Mechanical Engineer to join its R&D team in Germantown, MD. This onsite role focuses on medical devices through concept to manufacturing transfer, emphasizing design, validation, and product commercialization.

You will work with cross-functional teams and external suppliers to develop injection-molded components, electromechanical systems, and regulatory-compliant documentation for patient care devices.