Engineer I, Product Design

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

Position Summary

The Engineer I, Product Design position in the Vascular Access Product Engineering team will have the opportunity to manage product design changes for post market product in the medical field while collaborating with Product Design Engineers, Systems Engineers, R&D Testing Labs, Marketing, Design Assurance, as well as internal and external Manufacturing teams. The primary focus of this role will be supporting the post market development and performing design verification of medical device components and products of varying complexity. The engineer is responsible for developing and implementing design and development plans through adherence to established design control processes and good engineering and documentation practices. The position plays a key role in assisting in the supply continuity and compliance challenges involved with medical devices. Familiarity with Minitab and SolidWorks, or comparable statistics and CAD software, is a plus.

Essential Duties & Responsibilities

• Organizes, plans, and executes formal design verification activities for small to medium scale design change projects. Supports similar activities for other projects of varying scale.
• Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
• Supports risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and the identification and implementation of risk mitigation.
• Supports the analysis and evaluation of solutions to complex problems. Conducts investigations of varying complexity pertaining to the change in designs, methods, materials or processes, and investigates possible applications of the results.
• Assists in root cause analysis and the development and implementation of solutions for non-conforming events through the Corrective Actions and Preventable Actions (CAPA) process.
• Adheres to established design control processes and good engineering practices
• Designs and models components, devices, test fixtures, prototype/pilot tooling for various product lines using SolidWorks
• Develops test procedures to ensure specifications and regulations are met
• Executes engineering and validation studies on products
• Work on special projects as assigned

Knowledge & Skills

• Detail oriented and ability to organize large amounts of work and data
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, and team building
• Excellent project leadership and ability to expedite project completion
• Able to review and interpret technical documentation such as engineering drawings and component specifications
• SolidWorks competency preferred
• Minitab or similar statistics competency preferred
• Understanding of engineering mechanics and physics
• Able to analyze technical problems, develop creative solutions, and implement effective changes
• Familiarity with machine shop practices
• Familiarity of drafting standards

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
• Experience in Medical Device Product Development preferred.

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• 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