Engineer I, Manufacturing

ICU Medical; Southington (CT); On-site; USD 70,000 - 90,000; Full time

Job summary

ICU Medical is seeking a Manufacturing Engineer to join its team in Southington, Connecticut. The role focuses on supporting manufacturing process improvements and delivering project goals within specified timelines. Candidates should possess a Bachelor’s degree in Engineering or related fields and have at least 2 years of experience in the Medical Device or Engineering Industry.

The successful applicant will have knowledge of Six-Sigma methodologies and SolidWorks, alongside strong technical writing skills. This is a pivotal role that requires adherence to engineering best practices and FDA regulations.

Qualifications

• Understanding of automation, plastic injection molding, and process control techniques.
• Familiarity with FDA QSR Regulations.
• Ability to interpret part dimensions and conduct assembly.

Responsibilities

• Support process improvements and manufacturing systems.
• Assist in project timelines and CAPA tasks.
• Act as process technical expert for manufacturing production lines.

Skills

Understanding of strength of materials

Six‑Sigma methodology

Knowledge of the Medical Device Industry

SolidWorks knowledge

Technical writing competency

Education

Bachelor’s degree from an accredited college or university

2 years’ experience in the Medical Device or Engineering Industry

Job description

Position Summary

The Manufacturing Engineer will support the ICU Manufacturing Engineering Department and report to the Manufacturing or Product Engineering Manager. The Manufacturing Engineer is responsible for supporting manufacturing 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 & improvement.

Essential Duties & Responsibilities

• Day to day:
  • Support initiatives for continuous process and product improvements
  • Under the guidance of the Engineering leadership, improve performance of manufacturing systems (e.g., yield, cycle-time, quality requirements, maintenance needs)
  • Support project timelines and milestones and bring them to completion on time and within budget
  • Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
  • Act as process technical expert for a manufacturing production line
  • Create and edit documents to support Production
• Long‑term expectations:
  • Initiate and manage projects with adherence to program‑management guidelines
  • Participate in vendor assessment and review of materials/machine technical information
  • Build productive relationships internally and externally
  • Work with Quality Engineers on qualification activities for new or modified processes and equipment

Knowledge, Skills & Qualifications

• Understanding of strength of materials, automation, plastic injection molding, part assembly, 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 Regulations
• SolidWorks knowledge to interpret part dimensions, sectional views, conduct mates and build assemblies
• Technical writing competency

Education and Experience

• Must be 18 years of age
• Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM)
• 2 years’ experience in the Medical Device or Engineering Industry
• Advanced Degree may substitute for experience

Physical Requirements and Work Environment

• Employee is regularly required to talk or hear
• Role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines
• Work performed in a clean room environment
• Employee may be required to sit or stand for long periods of time
• Must be able to occasionally move and lift objects of up to 25 lbs
• Travel typically less than 5% of the time

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 CCPA Notice to Job Applicants