Engineer III, Product Design

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

Job Description

Position Summary

The Engineer III, Product Design position in the Vascular Access Product Engineering team will play a critical role in driving the design, development, and implementation of medical devices. This role involves collaborating closely with cross‑functional teams including marketing, commercial, quality, regulatory, and medical groups—to ensure that all product designs meet regulatory standards and customer expectations.

As a subject matter expert (SME) in medical device development, this position will drive key projects of significant complexity while applying sound engineering principles, experimental methods, and analytical techniques. The ideal candidate will bring extensive hands‑on experience in medical device design and development, with a strong background in documentation, testing, and risk management.

Essential Duties & Responsibilities

• Drive Design Control Activities: Work on all aspects of design control, including Requirements Management, Design Outputs, Verification & Validation (V&V), Design History File (DHF), and Risk File management.
• Drive Product Development: Plan, design, and implement new products and changes to post market products, ensuring compliance with applicable medical device standards.
• Solve Complex Engineering Challenges: Apply experimental, computational, and analytical methods to address technical challenges and ensure product performance.
• Develop and Maintain Technical Documentation: Create and maintain product specifications, requirements, architecture, design, and usability documents.
• Conduct and Oversee Testing: Design and execute exploratory, bench, and V&V testing, developing test protocols and generating comprehensive reports.
• Collaborate with Cross‑Functional Teams: Partner with marketing, quality, and regulatory teams to ensure design requirements align with business objectives and regulatory compliance.
• Corrective Actions and Preventable Actions: Assist manufacturing operations and quality with the root cause analysis, and the development and implementation of solutions for non‑conforming events.
• Design & Model Devices: Utilize SolidWorks to create and refine device models for various product lines, with a focus on high‑volume disposable medical devices.
• Partner with Suppliers & Customers: Collaborate with customers and suppliers to refine designs and ensure manufacturability, with an emphasis on plastics/polymer engineering and injection molding.

Knowledge & Skills

• Proven Expertise in Medical Device Design: Extensive hands‑on experience developing and improving medical devices, including knowledge of FDA regulations and ISO standards.
• Proficiency in SolidWorks: Strong capability in 3D modeling and drafting and the design for manufacturability.
• Material & Manufacturing Knowledge: Deep understanding of medical‑grade plastics, injection molding principles, and common joining methods.
• Analytical & Problem‑Solving Skills: Strong ability to apply statistical methods, including Design of Experiments (DOE) and tolerance analysis, to solve complex engineering problems.
• Strong Communication & Collaboration Skills: Ability to effectively communicate with technical and non‑technical stakeholders across departments and with suppliers.
• Knowledge of Engineering Mechanics & Physics: Solid understanding of the principles underlying mechanical design.
• Familiarity with Machine Shop Practices: Understanding of basic machining operations.
• Time Management: Ability to handle multiple priorities and meet key deadlines under pressure through effective time management skills.

Minimum Qualifications, Education & Experience

• Bachelor of Science (B.S.) degree in Mechanical Engineering or a related field from an accredited institution.
• Minimum of 4 years of relevant experience in medical device design and development.
• Must be at least 18 years of age.

Work Environment

• Primarily operates in a professional office environment with standard office equipment.
• This role is largely sedentary but may involve occasional visits to labs or manufacturing facilities.
• Typically requires travel less than 5% of the time.

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real‑world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically‑essential IV therapy and high‑value critical care products for hospital, alternate site, and home care settings.

We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You

• Dedicated and non‑dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV‑EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

ICU Medical CCPA Notice to Job Applicants