Senior Engineer, Manufacturing at ICU Medical, Inc. in Southington, Connecticut

Job Description:

Job Description



Job Title: Senior Engineer, Manufacturing-303


100% onsite in Southington CT


FLSA Status: Exempt


Position Summary


The Senior Manufacturing Engineer will support the ICU Manufacturing Engineering Department and report to the Manufacturing or Product Engineering Manager. The Senior Manufacturing Engineer is responsible for owning and driving process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined procedures during project support & improvements.


Essential Duties & Responsibilities


Functional area tasks and responsibilities

• Initiate and manage projects with adherence to program-management guidelines
• Own and manage CAPA tasks and deliverables (Corrective and Preventive)
• Lead vendor assessment and review of materials/machine technical information
• Identify and implement process and product modifications to improve manufacturability and impact on automation equipment
• Consult with Product and Molding Engineers on in-process non-conformances
• Process technical expert for multiple manufacturing production lines
• Create and edit documents to support Production
• Work with Quality Engineers on qualification activities for new or modified processes and equipment
• Spearhead initiatives for continuous process improvements
• Develop a broad understanding from start to end of the product manufacturing process in the company
• Perform design assessments, active participation in design reviews and risk management processes
• Network with senior internal and external personnel

Knowledge, Skills & Qualifications

• Substantial knowledge in one or more key process areas: automation, medical-device assembly or controls
• Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulation
• Solid works knowledge to interpret part dimensions, sectional views, conduct mates and build assemblies
• Technical writing competency

Education and Experience

• Must be at least 18 years of age
• Bachelor's degree from an accredited college or university in STEM discipline
• 7+ years' experience

Physical Requirements and 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 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