Design Engineer - Medical Device

JOB TITLE: Design Engineer, Medical Devices & Manufacturing Transfer

COMPANY OVERVIEW

Our client is a pioneering force in critical care, committed to revolutionizing patient outcomes through innovative medical devices. As a leading provider of cutting-edge

solutions, we specialize in continuous, real-time monitoring products. Designed to seamlessly integrate into existing medical environments, our devices reduce clinical workload

while delivering unparalleled accuracy and reliability.

POSITION SUMMARY

We are seeking a dynamic Design Engineer with manufacturing transfer experience to join our team. This role is pivotal in elevating our products to the next level of production, particularly in the development and optimization of our innovative medical devices. The ideal candidate will have a strong passion for medical technology and a hands-on approach to problem-solving and design optimization.

We are specifically looking for individuals with experience in design transfer-to-manufacturing and cost reduction through protocol updates and turnkey fixture design. Future opportunities exist for new product innovation and design. You would also get the opportunity to be mentored by the Director of Engineering and teach / lead junior engineers / interns.

The Design Engineer role will grow to become our subject matter expert / product lead for our product line. This would involve product upkeep, supplier management, clinical team support, manufacturing ramp, etc.

KEY RESPONSIBILITIES

• Work to become a subject matter expert and primary technical point of contact.
• Support ongoing manufacturing efforts by evaluating protocols, recommending, and building fixtures to improve throughput. This may involve working on-site on manufacturing floors (primarily in NC).
• Work with clinical teams to support product deployment and any required debugging efforts.
• Participate in all prototyping, testing, and validation processes to ensure product safety.
• Work with cross-functional teams to design and refine medical devices from concept to production.
• Supervise and lead junior and intern engineers

QUALIFICATIONS

• Bachelor’s degree in Mechanical or Biomedical Engineering, Comp. Sci./EE, or a related field.
• 5+ years of experience in design engineering, prototyping, or manufacturing support engineering
• Demonstrable proficiency for independent workflow in two of the following, at a minimum:

o Mechanical design and physical prototyping (Solidworks, 3D printing, laser cutting, etc.)

o Firmware/Software Design (C, C++, Python)

o Electrical schematic capture and PCB layout, Circuit Debugging (Eagle, Altium)

o Manufacturing process optimization & tool/jig development, ideally with medical devices

• Startup experience; Strong problem-solving skills with a creative and innovative mindset.
• Excellent communication skills and ability to work effectively in a collaborative environment.
• Experience in change control/documentation control in medtech would be a big +

WHY JOIN US? Our client offers a unique opportunity to join a dynamic team dedicated

to saving lives. As a member of our company, you will have the chance to work on cutting-edge medical devices that directly impact patient care. We value creativity, innovation, and a passion for making a difference. Our supportive environment encourages professional growth and allows you to tailor your career path according to your interests and expertise.

If you're seeking a challenging role in medical technology and are eager to contribute to our mission, we invite you to join our team.

Mid-Sr. Design Engineer role, 5-7 years of experience. Ideally, with manufacturing transition expertise and experience supporting a medical product. They could become a product owner for our first-generation product, help optimize manufacturing, and work with the Director of Engineering to design/test the next-generation products.