Senior Medical Device Design Engineer - 510(k) & PM

Medline Industries, Inc. in; Northfield Township (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 in Northfield, IL seeks a senior product design lead to manage multi-disciplinary teams, oversee design and development of medical devices, and coordinate from ideation to 510(k) submission and launch.

Requires a bachelor's in engineering, 7+ years in product design, SolidWorks expertise, and experience with Class I-II devices, design controls, and the 510(k) process; travel up to 10%.

Qualifications

• Bachelor's degree in mechanical, biomedical, electrical, or software engineering.
• 7+ years of experience in product design.
• Experience with SolidWorks and prototype fabrication.
• Experience with medical device requirements (Class I-II), design controls, and the 510(k) process.

Responsibilities

• Lead multi-disciplinary product development teams to design and develop new products and technologies.
• Collaborate with regulatory, quality, legal, manufacturers, and divisions to ensure designs meet requirements and launch successfully.
• Develop design specifications, manage multiple project timelines, and balance priorities for product development projects.
• Coordinate product design and laboratory teams to verify and validate inputs and support launches.

Skills

Team leadership

Cross-functional collaboration

SolidWorks

Prototype fabrication

Design controls

Education

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

Tools

SolidWorks

Microsoft Project

Job description

Medline Industries, LP in Northfield, IL seeks a senior product design lead to manage multi-disciplinary teams, oversee design and development of medical devices, and coordinate from ideation to 510(k) submission and launch.

Requires a bachelor's in engineering, 7+ years in product design, SolidWorks expertise, and experience with Class I-II devices, design controls, and the 510(k) process; travel up to 10%.