Job Description
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
- Day to day
- 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
- Long term expectations
- 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, controls, etc
- 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 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)
- Medical Device Experience is a must
- 8 years combined 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
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 humanresources@icumed.com. 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
