Senior Medical Device Design Engineer

ICU Medical; Southington (CT); On-site; USD 105,000 - 140,000; Full time

Job summary

ICU Medical is seeking an Engineer III, Product Design for the Vascular Access Product Engineering team in Southington, CT. You will drive design, development, and implementation of medical devices, coordinating with marketing, quality, regulatory, and medical groups to meet regulatory standards and customer needs.

As a SME in medical device development, you will lead projects of significant complexity, applying robust engineering practices, documentation, testing, and risk management to ensure

Qualifications

• BS in Mechanical Engineering or related field from an accredited institution.
• 4+ years of relevant experience in medical device design and development.
• Experience with design control, documentation, risk management, and V&V.

Responsibilities

• Drive Design Control Activities: manage Requirements, Design Outputs, V&V, DHF and Risk File.
• Drive Product Development: plan, design and implement new products and changes to post‑market products.
• Solve Complex Engineering Challenges: apply experimental, computational, and analytical methods for performance.
• Develop and Maintain Technical Documentation: create specs, requirements, architecture, design, usability docs.
• Conduct and Oversee Testing: design/execut e exploratory, bench, and V&V tests; produce reports.
• Collaborate with Cross-Functional Teams: align design with regulatory and business goals.
• Corrective Actions and Preventable Actions: assist root cause analysis and implement solutions for non-conformances.
• Design & Model Devices: use SolidWorks for device models; focus on high-volume disposable devices.
• Partner with Suppliers & Customers: refine designs for manufacturability, plastics/polymer engineering, injection molding.

Skills

Medical device design

3D modeling

Regulatory knowledge

DOE

Cross-functional collaboration

Design for manufacturability

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks

Job description

ICU Medical is seeking an Engineer III, Product Design for the Vascular Access Product Engineering team in Southington, CT. You will drive design, development, and implementation of medical devices, coordinating with marketing, quality, regulatory, and medical groups to meet regulatory standards and customer needs.

As a SME in medical device development, you will lead projects of significant complexity, applying robust engineering practices, documentation, testing, and risk management to ensure