Product Design Engineer I - Medical Devices

Socket.dev; Southington (CT); On-site; USD 65,000 - 90,000; Full time

Job summary

ICU Medical is seeking an Engineer I, Product Design to support post-market product design changes within the Vascular Access Product Engineering team. You will manage design verification activities, develop and implement design plans, and ensure compliance with design control processes and documentation practices.

You will collaborate with design engineers, systems engineers, R&D labs, marketing, design assurance, and manufacturing teams to maintain supply continuity and address compliance

Qualifications

• Bachelor of Science degree in Mechanical Engineering or related field; Master’s Degree preferred.
• Experience in Medical Device Product Development preferred.

Responsibilities

• Organizes, plans, and executes formal design verification activities for design change projects.
• Writes test protocols, performs test method validations, and authors test reports with data analysis.
• Supports risk management through hazard analysis, DFMEA, and risk mitigation.
• Analyzes and evaluates solutions to complex problems; investigates design changes and materials.
• Assists in CAPA process for corrective actions and preventive actions.
• Designs and models components and fixtures using SolidWorks; develops test procedures.

Skills

Detail oriented

Strong communication

Project leadership

Review technical documentation

SolidWorks competency

Minitab competency

Engineering mechanics

Creative problem solving

Drafting standards

Education

Bachelor of Science in Mechanical Engineering

Master's Degree preferred

Tools

SolidWorks

Minitab

Job description

ICU Medical is seeking an Engineer I, Product Design to support post-market product design changes within the Vascular Access Product Engineering team. You will manage design verification activities, develop and implement design plans, and ensure compliance with design control processes and documentation practices.

You will collaborate with design engineers, systems engineers, R&D labs, marketing, design assurance, and manufacturing teams to maintain supply continuity and address compliance