Entry-Level Medical Device Product Design Engineer

RXinsider LTD.; Southington (CT); On-site; USD 70,000 - 100,000; Full time

Job summary

ICU Medical in Southington, CT is seeking an Engineer I, Product Design to manage design changes for post-market medical devices. You will collaborate with product design, systems engineering, R&D testing, marketing, design assurance, and manufacturing teams to ensure design verifications meet specifications.

The role emphasizes adherence to design control processes, documentation practices, and risk mitigation through DFMEA and CAPA, with opportunities to develop SolidWorks models and run

Qualifications

• BS in Mechanical Engineering or related field; MS preferred.
• Experience in medical device product development preferred.
• Must be at least 18 years old.

Responsibilities

• Plan and execute design verification activities for design changes.
• Write test protocols and perform validations with data analysis.
• Support risk management including DFMEA and mitigation.
• Analyze complex design change problems and investigate solutions.
• Assist CAPA process for non-conforming events.
• Adhere to design control processes and good engineering practices.
• Design and model components and tooling in SolidWorks.
• Develop test procedures to meet specs and regulations.
• Conduct engineering and validation studies.
• Work on special projects as assigned.

Skills

Design verification

DFMEA

CAPA process

SolidWorks

Minitab

Data analysis

Project leadership

Technical documentation

Education

Bachelor of Science in Mechanical Engineering

Master's degree preferred

Tools

CAD software: SolidWorks

Minitab

Job description

ICU Medical in Southington, CT is seeking an Engineer I, Product Design to manage design changes for post-market medical devices. You will collaborate with product design, systems engineering, R&D testing, marketing, design assurance, and manufacturing teams to ensure design verifications meet specifications.

The role emphasizes adherence to design control processes, documentation practices, and risk mitigation through DFMEA and CAPA, with opportunities to develop SolidWorks models and run