Senior Medical Device Design Engineer – 510(k) & Innovation

Medline; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks an experienced product design leader to oversee multi-disciplinary teams and guide the design and development of new medical products and technologies. You will ensure design specifications meet requirements, manage timelines, and collaborate with customers, manufacturing, quality, and regulatory groups to deliver high-quality launches.

Lead design assignments, coordinate ideation through 510k submission, review existing products for improvements, and support

Qualifications

• Bachelor's degree in mechanical/biomedical/electrical/software engineering.
• At least 7 years of experience in product design.
• Experience with SolidWorks/3D modeling and prototype fabrication.
• Certified SolidWorks Professional.
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
• Experience designing and launching class II medical devices to market.
• Experience with project management, Microsoft Project, and leading multi-disciplinary teams.
• Invented and recognized on at least one patent.
• Position requires travel up to 10% of the time (domestic and international).
• Knowledge of injection molding and other manufacturing processes.

Responsibilities

• Manage multi-disciplinary product development teams to design and develop new products and technologies.
• Collaborate with customers, quality, regulatory, legal, manufacturers, and divisional personnel to ensure designs meet requirements and launch successfully.
• Develop design specifications and manage multiple project timelines to meet deadlines.
• Identify opportunities, establish innovation pipelines, and align efforts with long-term strategies.
• Coordinate all phases of product development from ideation to 510k to launch.
• Review existing products and propose improvements based on feedback and risk analyses.
• Support design transfer to manufacturing sites and validate designs with manufacturers.
• Coordinate design and lab teams to verify and validate inputs.
• Contribute to new product designs, prototypes, and technical drawings.

Skills

SolidWorks

3D modeling

Prototype fabrication

Project management

Cross-functional leadership

Travel up to 10%

Education

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

Tools

Microsoft Project

Excel

Job description

Medline Industries, LP seeks an experienced product design leader to oversee multi-disciplinary teams and guide the design and development of new medical products and technologies. You will ensure design specifications meet requirements, manage timelines, and collaborate with customers, manufacturing, quality, and regulatory groups to deliver high-quality launches.

Lead design assignments, coordinate ideation through 510k submission, review existing products for improvements, and support