Senior Engineer, Product Design at ICU Medical, Inc. in Southington, Connecticut

Job Description:

Job Description



Position Summary


The Sr. Engineer will support the Research and Development engineering team within ICU Medical's Consumables business unit which includes Vascular Access. As part of this team you will have a pivotal role in the research, development, and implementation of new products using specialized knowledge and skills typically acquired through advanced education. There will be an emphasis on Systems Engineering and Risk Management.

The Sr. Engineer can plan, lead and complete projects/matters of intermediate to high complexity working independently or with a team. Receives technical mentorship on complex problems, but independently resolves using new, improved or novel approaches and solutions. The Senior R&D Engineer will be expected to serve as the subject matter expert on a variety of topics. They will drive actionable project level tasks while adhering to established design control processes and good engineering and documentation practices.

The Sr. Engineer will be enthusiastic to develop their Product Development core competencies as well as their ability to direct, coach, mentor and align a cross functional team as needed.



Essential Duties & Responsibilities

• Contributes to project planning: milestones, schedules, budgets, key decisions
• Defines Systems Architecture, Document Hierarchy and DHF structure
• Plans and executes Voice of the Customer activities, defines and translates User Needs to Design Input Technical Specifications
• Defines applicable standards and regulations
• Leads risk management activities such as Hazard Analysis
• Contributes to design and process failure and effects analyses (DFMEA and PFMEA)
• Maintains requirement, risk management, and verification / validation traceability
• Identifies and familiarizes with relevant clinical research, competitive landscape and prior art
• Invents practical solutions that advance the state of the art
• Collaborates with Design and Manufacturing Engineers to develop functional prototypes
• Plans feasibility, verification and validation activities in collaboration with cross functional team
• Performs characterization as required: establishes test plans, writes test protocols and methods, and authors test reports with data analysis and technical conclusions.
• Provides technical support to regulatory, sales, marketing and other functional areas as needed.
• Work on special assignments as they arise
• Engages others, promotes, and participates in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
• Experience with root cause analysis, CAPA and NCR processes.
• Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)

Knowledge & Skills

• Ability to quickly learn new concepts and technologies
• Proven hands-on experience developing medical devices in a gated development process
• Knowledge of manufacturing processes: machining, metal forming, extrusion, injection molding, common joining methods, etc.
• Experimental, computational and analytical skills such as DFSS tools, statistical methods including design of experiments (DOE) and MiniTab
• Familiarity with ISO standards, including 13485, 14971, 62366, and 10555.
• Highly desirable: expertise in Risk Management
• Comfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactions
• Good interpersonal, verbal and written communications skills.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor of Science degree from an accredited college or university in Mechanical or Biomedical Engineering or a related field with 7 years experience. Advanced degree in related field preferred.

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• May require travel up to 20% 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 fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and 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 identity, gender expression, gender reassignment, 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 humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement


OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants Apply Now