Engineer I, Manufacturing

ICU Medical; Southington (CT); On-site; USD 75,000 - 110,000; Full time

Job summary

ICU Medical is seeking a Manufacturing Engineer to support the Manufacturing Engineering Department by driving process improvements and adhering to design control and documentation practices. You will exercise judgment within defined procedures while assisting in project support and continuous improvement efforts.

You will collaborate with manufacturing leadership to improve yield, cycle-times, quality, and maintenance needs, while ensuring projects meet schedules and budgets.

Qualifications

• Bachelor’s degree in Engineering, Technology, or STEM from an accredited college or university.
• Minimum 2 years of experience in the Medical Device or engineering industry.
• Advanced degree may substitute for experience.

Responsibilities

• Support initiatives for continuous process and product improvements.
• Improve performance of manufacturing systems (yield, cycle-time, quality).
• Support project timelines and milestones and bring them to completion on time and within budget.
• Assist in completion of CAPA tasks and deliverables.
• Act as process technical expert for a manufacturing production line.
• Create and edit documents to support Production.
• Initiate and manage projects with program-management guidelines.
• Participate in vendor assessment and review of materials/machine information.
• Build productive relationships internally and externally.
• Work with Quality Engineers on qualification activities for new or modified processes and equipment.

Skills

Strength of materials

Automation

Plastic injection molding

Part assembly

Fixturing

Testing

Process control

Six-Sigma

DOE

Gage R&R

FDA QSR

SolidWorks

Technical writing

Education

Bachelor’s degree in Engineering/Technology/STEM

2 years’ experience in Medical Device or Engineering Industry

Advanced Degree may substitute for experience

Tools

SolidWorks

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

• Functional area tasks and responsibilities
  • Day to day:
    • Support initiatives for continuous process and product improvements
    • Under the guidance of the Engineering leadership, work to 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)
    • 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
• Solid works 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

• While performing the duties of this job, the employee is regularly required to talk or hear.
• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Work is performed in a clean room environment
• While performing the duties of this job, the 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.
• Typically requires travel less than 5% of the time