Senior Medical Device Design Lead

Medline; Eagan (MN); Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Travel up to 10%

Job summary

Medline Industries, LP is hiring a Principal Design Engineer in Eagan, MN for hybrid work. You will manage design teams, coordinate across departments, and drive product development from concept to 510(k) clearance and launch.

The role requires a strong background in mechanical/biomedical/electrical/software engineering with 7+ years in product design, SolidWorks proficiency, and experience in medical devices and regulatory processes.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or software engineering.
• At least 7 years of experience in product design.
• Experience with Solidworks/3D modeling software and prototype fabrication.
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.

Responsibilities

• Manage multi-disciplinary product development teams to research, design, and develop new products and technologies.
• Collaborate with customers, quality, regulatory, legal, manufacturers, and divisional personnel to ensure new product designs meet all requirements and launches.
• Develop design specifications, manage multiple project timelines, and balance priorities for product development projects.
• Coordinate product development across divisions to identify opportunities and align with long-term strategies.
• Coordinate design and lab teams through ideation, validation, and 510k to launch.

Skills

Solidworks/3D modeling

Prototype fabrication

Project management

Leadership/coordination

Regulatory awareness

Education

Bachelor's degree in mechanical/biomedical/electrical or software engineering

Certified Solidworks Professional

Tools

Solidworks

Microsoft Project

Job description

Medline Industries, LP is hiring a Principal Design Engineer in Eagan, MN for hybrid work. You will manage design teams, coordinate across departments, and drive product development from concept to 510(k) clearance and launch.

The role requires a strong background in mechanical/biomedical/electrical/software engineering with 7+ years in product design, SolidWorks proficiency, and experience in medical devices and regulatory processes.