Position Summary
The Product Sustaining Engineer III is responsible for supporting product 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.
The Product Sustaining Engineering III will complete advanced engineering projects with input and guidance from senior engineers and managers. Gains exposure to some of the complex tasks within the job function.
Essential Duties & Responsibilities
- Support initiatives for continuous process and product improvements
- Work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance's 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)
- Identify and qualify "end-of-life" components.
- Represent Sustaining Engineering to identify possible product modifications to improve manufacturability and impact on production processes.
- Initiate and manage projects with adherence to program management guidelines
- Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
- Conducts independent analysis and develops solutions to problems.
- Develops approaches and designs where precedent usually exists.
- Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.
- Writes detailed design specifications.
- Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
- Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
- Work on special projects as they arise
Knowledge, Skills & Qualifications
- Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
- Knowledge of Solidworks to interpret part dimensions, sectional views, conduct mates, build assemblies.
- Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
- Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations is a plus
- Competent in your domain. Familiar with other areas of domain expertise within the team.
- Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
- Have awareness of the broader product strategy and contribute to it
- Ability to receive general project direction and solicit input from more experienced engineers.
- Requires the ability to independently make decisions that impact the attainment of project
Minimum Qualifications
- Must be at least 18 years of age
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
- 4+ years of experience in Medical Device Product Development or related field
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
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.
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