Senior Medical Device Design Engineer

RXinsider LTD.; Southington (CT); On-site; USD 110,000 - 145,000; Full time

Job summary

ICU Medical in Southington, CT seeks an Engineer III, Product Design to drive design, development, and implementation of medical devices. You will collaborate with marketing, quality, regulatory, and medical groups to ensure regulatory compliance and customer satisfaction.

The role emphasizes hands‑on device design, documentation, testing, and risk management, with experience in SolidWorks and DFx considerations for high‑volume disposables.

Qualifications

• BS in Mechanical Engineering or related field from an accredited institution.
• Minimum of 4 years of medical device design and development experience.
• Experience with design controls, V&V, DHF, and risk management.
• Proficient in 3D modeling and manufacturability considerations.
• Strong communication and cross‑functional collaboration skills.

Responsibilities

• Drive design control activities across requirements, V&V, DHF and risk files.
• Plan, design, and implement new post‑market and in‑line product changes.
• Apply experimental, analytical methods to solve complex engineering problems.
• Create and maintain product specifications, architecture and usability docs.
• Design and execute bench and V&V tests with detailed reports.
• Collaborate with marketing, quality and regulatory teams.
• Assist with root cause analysis and corrective actions.
• Model devices using SolidWorks for high‑volume disposables.
• Work with suppliers and customers to refine designs and manufacturability.

Skills

SolidWorks

FDA/ISO knowledge

DOE

Tolerance analysis

Statistical methods

Communication

Mechanical design

Machining basics

Time management

Education

B.S. Mechanical Engineering

Tools

SolidWorks

MATLAB

Job description

ICU Medical in Southington, CT seeks an Engineer III, Product Design to drive design, development, and implementation of medical devices. You will collaborate with marketing, quality, regulatory, and medical groups to ensure regulatory compliance and customer satisfaction.

The role emphasizes hands‑on device design, documentation, testing, and risk management, with experience in SolidWorks and DFx considerations for high‑volume disposables.