Senior Engineer, Product

Position Summary

The Sr. Engineer, Product is responsible for owning and driving product improvements through adherence to established design control processes, good engineering and documentation practices. They are considered a specialist on complex technical and business matters, may assume a team lead role for work in the group and be highly independent in accomplishing work. The key responsibility of this position is to completes advanced engineering projects with peer input and guidance from engineering management, exercising judgement and taking action while adhering to defined procedures during project support & improvements.

Essential Duties & Responsibilities

• Immediate expectations

• Receives general project direction. Responsible for project progress.

• Analyze, plan, organize and complete projects of a very complex nature. Develops scope and provide creative solutions. Plans, organizes and conduct technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.

• Initiate and manage projects with adherence to program management guidelines

• Perform Design assessments, active participation in Design reviews, Risk Management processes.

• Own and manage CAPA tasks and deliverables (Corrective and Preventive)

• Coordinate efforts with the Materials Group to assess vendors and provide materials technical information

• Represent Product Engineering to identify possible product modifications to improve manufacturability and impact on automation equipment

• Maintain Product specifications; consult with manufacturing on product non-conformance.

• Work on special projects as they arise

• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.

• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus

• Long term expectations

• Spearhead initiatives for continuous process and product improvements (assess tolerance stack up of sustaining designs to increase robustness)

• Develop a broad understanding from start to end of the product manufacturing process in the company

• Network with senior internal and external personnel

• Intellectual Property review and assessment

• Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.

Knowledge & Skills

• Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
• Solid works to interpret part dimensions, sectional views, conduct mates & build assemblies. Able to run basic simulations.
• Risk Management, FMEA generation and Risk Analysis
• 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
• Has mastered best practices. Has an advanced understanding of engineering discipline
• Can assess what work supports the product strategy and make insightful recommendations regarding priorities
• Expert in your domain of expertise. Familiar in other areas of domain expertise within the team.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor's degree from an accredited college or university (Engineering or Technology)
• 7+ years' experience

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Work may be 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; depending on the machine they are operating
• Must be able to occasionally move and lift objects of up to 25 lbs
• 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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