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

Medline Industries, Inc.

Eagan (MN)

On-site

USD 116,000 - 174,000

Full time

6 days ago

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Job summary

Medline Industries, Inc. in Minnesota is seeking a Senior Product Design Engineer to manage multi-disciplinary product development teams and guide the design of new medical devices from concept through 510(k) submission and launch.

The role requires a Bachelor's degree in mechanical, biomedical, electrical, or software engineering; 7+ years in product design; Proficiency in SolidWorks; and experience with polymers, risk assessments, design controls, and FDA 510(k) processes in the medical device

Qualifications

Bachelor's degree in mechanical, biomedical, electrical, or software engineering.
7+ years of product design experience; SolidWorks proficiency; prototype fabrication.
Certified SolidWorks Professional preferred; 10+ years experience; medical device industry knowledge.

Responsibilities

Lead multi-disciplinary product development teams to design and develop new products.
Collaborate with customers, quality, regulatory, and manufacturers to ensure launches.
Develop design specifications and manage multiple project timelines.
Coordinate ideation through 510k and product launch.
Review existing products and implement improvements from feedback.
Support design transfer to manufacturing and validate designs with suppliers.
Contribute to IP development and manage day-to-day team activities.