ICU Medical currently has an open position for a Supply Chain Rep, located in San Clemente, California.

TheSupply Chain Rep will provide detailed guidance and support to ICU Medicals customers regarding all supply chain activities, these activities will include Conversions, Forecast, expedites, Estimated ship date, business model changes Etc… This role is responsible for insuring that all data and actions that are required to meet customers and ICU expectations are followed through.

Key Responsibilities Include:

• Manage Customer Conversion to ICU products (20% of week)
• Manage Customer conversions to 30day lead-time model (20% of week)
• Work with Distributor to provide accurate forecasting (20% of week)
• Manage key expedites to insure customer expectations are met (20% of week)
• Work with Distributors/ICU PSRs to insure all expectations are covered (20% of week)

Skills Needed:

• Enjoys a fast paced, challenging environment.
• Ability to manage multiple priorities and consistently meet specific, time sensitive tasks.
• Is empathetic towards customers and strives to delight them.
• Excellent Verbal and Written Communications.
• Ability to effectively troubleshoot and resolve issues.
• Ability to develop and deploy effective, meaningful metrics and reports.
• Proven ability to meet deadline in a fast paces changing environment.
• Strong technical troubleshooting skills.
• Proficient with Microsoft office.
• ERP System experience.
• Project Management experience.

Qualifications:

• Project management training
• Experience working with a Sales, Customer service , Sales support (1-2 Yrs)
• Previous Planning experience (1 yr)
• Bachelors degree ( Preferred)
• Planning/Forecast experience (Preferred 1 yr)
• Oracle ERP System ( Preferred)
• Medical Experience (preferred )

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Set Design Engineer, located in San Clemente, California.

Major Accountabilities:

• Develop new products and components for custom sets.
• Engineering analysis of purchased components.
• Operate within specifications and guidelines for a product.
• Ensure profitability through better manufacturing processes.
• Support manufacturing engineers in validation and assembly procedures.

Duties and Responsibilities:

• Perform market research as required to define clinical performance criteria and develop engineering performance specifications for tubing set components.
• Evaluate new or changed components for use in tubing sets.
• Audit the RitePart database and SetMaker stencils to assure all data is accurate, complete and supported by appropriate documentation.
• Document time and activities using ChangeMaker™.
• Write engineering performance specifications when needed and assure that all specifications define and test for clinically acceptable standards.
• Review justification requests and process for Qumas approval where appropriate. Initiate EAR qualification for relationships that can’t be justified.
• Define and distribute preferred set design standards to be used unless otherwise specified by customers.
• Coordinate with Product Development, Purchasing and the OPS Team to develop actionable sourcing requirements.
• Participate in the NLR and customer complaint process to assure dispositions do not create customer satisfaction issues and that Quote Center design standards remain up-to-date.

Requirements:

• Minimum six (6) years experience overall, three (3) as a lead or project engineer, 1-2 years in the medical device industry.
• Bachelor of Science degree in Mechanical Engineering or equivalent discipline; Masters or advanced degree preferred.
• Knowledge of materials (emphasis on medical plastics) and medical device manufacturing practices.
• Engineering mechanics and physics, machine shop practice, drafting standards, and ability to work with others and expedite project completion, and project leadership.
• Must possess excellent computer skills.
• Occasional (3-6 times annually) travel to Ensenada, Salt Lake City and Slovakian manufacturing plants required.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for an Engineering Laboratory Technician, located in San Clemente, California.

The Engineering Laboratory Technician will:

• Assist in the development and writing of test protocols.
• Perform testing on ICU and competitive products.
• Perform statistical analysis of test results.
• Document test results in a report format and maintain in QMAS.
• Support R&D staff in prototype development and testing.
• Ensure cleanliness and organization of the lab.
• Maintain supplies for the lab. 8. Laboratory equipment validation and maintenance.
• Set and follow project plans using ChangeMaker™

Qualifications:

• Bachelors Degree desired.
• Previous experience testing medical devices required.
• Technical knowledge in the field required.
• Knowledge of physical sciences, statistics, laboratory equipment.
• Good organizational and communication skills required.
• Must be computer literate.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Training Specialist, located in Salt Lake City, Utah.

The Training Specialist will organize, coordinate and conduct training curriculum, plans and programs ; Conducts needs assessment and plan, design and implement training programs and activities; Writes and/or modifies training materials and programs; Research, evaluates and purchases training resources and materials; Coordinates outside training resources, to include grant development, and;

• Coordinate with key internal partners to develop and execute training programs.
• Provide strategic input and direction toward successful accomplishment of the company’s short and long term strategic plan and mission. This includes leadership development and team building exercises.
• Facilitate projects that promotes continuous improvement processes w/ Lean Manufacturing and Six Sigma tools.
• Coordinate activities for ICU University implementation.

Essential Qualifications:

• Four year college degree (Training, Teaching and/or OD degree/curriculum a plus)
• 3-5 years of experience as a Corporate and/or Site Trainer (training must have been sole responsibility)
• Six Sigma Green Belt certified is a plus
• Experience working in a lean manufacturing environment is a plus
• Knowledge and skill in Microsoft Office (including Word, Excel and PowerPoint)

Additional Qualifications:

• Ability to work well with others in the design of training material consistent with company objectives.
• Ability to coordinate company-wide training activities from conceptualization and planning to successful execution.
• Well organized and flexible in planning and implementing successful training programs with the ability to evaluate programs to produce immediate and consistent results.
• Demonstrated ability to manage multiple projects from conceptualization to measurement.
• Ability to motivate personnel to take advantage of training resources and opportunities.
• Knowledgeable in and practical experience with a variety of training concepts, practices and procedures that are effective with adult learners.
• Responsible for knowledge of current competitive training practices. Participation in learning opportunities, both within and outside the company.
• Ability to maintain effective listening, written and oral communication during the performance of job responsibilities.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Project Manager, located in Salt Lake City, Utah.

In this NEWLY-CREATED position within our busy marketing department, you will oversee planning and management of R&D Projects. This position will require the ability to manage a few large and numerous small, very diverse projects with a strong emphasis on resource allocation in project management software. This will require good judgment in how to define tasks, clarify responsibility and track resource time, without “bogging down” in detail.

Daily tasks would include:

• Select a project task template and adjust the task list as required by the nature of each project. Review and adjust the estimated hours and duration for each project to propose a complete project schedule and end date.
• Create new project templates as required.
• Analyze resource time availability and work with resource managers to identify a team.
• Schedule and lead team meetings as required to keep the project on schedule.
• Communicate with resources regarding deliverable status and help to resolve obstacles where possible.
• If resource availability impacts a project deadline, communicate with management to clarify priorities. If the project schedule can't be revised, work with resource managers to identify additional resources or changes to the process required to stay on schedule.
• Review deliverable status as reported by task owners in the project schedule on a daily basis.
• Monitor and report on the project budget and resource performance.

In addition to the above, this position will be involved in standardizing processes between our various geographically-diverse plants. Position will also be responsible for documenting procedure changes and training new PM software users, and other related tasks as required.

Qualifications:

• Five (5) years manufacturing project management experience, preferably in medical device.
• Bachelor’s degree.
• Must be proficient with Microsoft Project or similar program.
• Project Management certification desirable.
• Experience in high growth environments, experience in more than one company.
• Additional experience in planning, technical writing, quality control, production management desirable.
• Familiarity with Oracle, Access, and Visual Basic desirable.
• Ability to lead others and make decisions.
• Good communication skills.
• Must be flexible and able to change plans quickly.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Manufacturing Engineer, located in Salt Lake City, Utah.

The Manufacturing Engineer is responsible for all technical aspects of product/process design with emphasis on manufacturability and time to market. This individual must drive improvements and redesign of existing products/processes; identify cost reduction initiatives; define and implement equipment and automation; and provide support to Maintenance and Manufacturing in the facility. Must have a strong hands-on approach and aggressive problem solving attitude. Must establish project schedules and complete them on time and within budget.

Required experience and qualifications include, but are not limited to:

• Medical device design, development and manufacturing experience, in addition to familiarity with FDA QSR/ISO Regulations.
• Experience designing products for high volume manufacturing, utilizing injection molding and automated assembly processes.
• Must have excellent analytical skills (Six-Sigma/Lean) and fundamental engineering knowledge including stress analysis (FEA), mechanical design, thermal analysis, and fluid dynamics.
• Must have a thorough knowledge of thermoplastics, silicone material properties and associated molding and automation processes.
• Experience with validations and documentation requirements of the Medical Device Industry.
• Solid modeling via SolidWorks and experience with ASME Y14.5, ISO, and GD/T principles is desirable.

Qualifications:

• BS in Mechanical Engineering or equivalent, MS or MBA preferred.
• 5-10 years experience in the Medical Device Industry related engineering in a high-speed production environment.
• Six sigma experience (Black Belt preferred).

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Automation Engineer, located in Salt Lake City, Utah.

Responsible for design and implementation of automation systems for high-speed, high-volume automated production of medical devices. Responsibilities include both design and procurement of custom process automation machines, equipment, systems, and fixtures to satisfy specific requirements.

Required experience and qualifications include, but are not be limited to:

• Medical device experience and familiarity with FDA QSR/ISO 9000/ISO 13485 regulations.
• Determine machine requirements, evaluate needs and translate them into feasible and economical equipment solutions.
• Lead detailed engineering design activities to deliver functional machine solutions.
• Create detailed conceptualizations, detailed designs, process maps, and tolerance analyses for form, dimensional fit, and overall functionality.
• Lead FMEA and risk analysis activities.
• Provide knowledge on capabilities of key automation suppliers and providers of automation design and equipment manufacturing. Evaluate suppliers and make recommendations for selection.
• Work with Manufacturing personnel to improve performance of manufacturing systems, e.g. yield, speed, personnel requirements, maintenance needs. Consider factors such as ease of setup, changeover and maintenance, reliability, biocompatibility, contamination control and economy.
• Identify possible product modifications to improve manufacturability.
• Possess a thorough understanding of strength of materials, kinematics and dynamics, vibration, fluid flow as well as plastic injection molding and part assembly, bowl feeders, product handling, part transfer and fixturing, process tooling, pneumatics, cam devices, stepper/servo motors, drive systems, slide systems, sensor technologies and application, vision systems, and machine control systems.
• Solid modeling via Solid Works and experience with ASME Y14.5, ISO, and GD/T principles PMBOK certification a plus.
• Familiarity with Six Sigma, LEAN manufacturing or other vigorous quality control programs is desirable.
• BS in Mechanical Engineering or equivalent, MS or MBA preferred.
• 5-10 years experience designing high volume automated assembly processes.

Qualifications:

• One year previous experience in manufacturing environment is preferred, but not required.
• High school diploma, GED, or equivalent experience.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Technical Customer Service Representative, located in San Clemente, California.

The Technical Customer Service position provides customer and repair support to internal and external customers, resolves technical and operational questions regarding ICU Medicals infusion and critical care monitoring systems. This position will also be processing customer orders and repair requests.

Key Responsibilities Include:

• Provide technical and operational direction to health care professionals responsible for the repair and analysis of product, troubleshooting non-functional devices and providing spare part order entry to ensure continuity of service, utilizing order entry system(s) to process orders.
• Maintain customer concerns in appropriate databases, recognizing issues that need to be escalated.
• Actively participate in the Repair Only service by relating technical information to the customer.
• Effectively execute plans to manage customer interactions to obtain closure of field corrections, upgrades, and recalls in a timely manner.
• Assist in all other customer service related activities.

Skills Needed:

• This position requires a high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customer's (including field sales and service representatives) questions. The position also requires the ability to work under pressure and stress common to office environments. The specialist must be able to knowledgeably enter and retrieve information from the ICU Software Systems.
• Thorough understanding of customer needs and expectations, as well as ability to deal with various types of customers.
• Ability to effectively resolve complex customer issues.

Qualifications:

• Associates Degree in Biomedical Technology or equivalent experience
• Experience with working in a Customer Call Center environment (2 years)
• Biomedical Technician or equivalent experience (1-2 years)
• Use of SAP (or similar) Order Management System (1-2 years)
• Use of MS Office suite of software applications (1-2 years)

Preferred Qualifications:

• Registered nurse 5+ year’s exp.
• Bachelors degree
• Oracle ERP System
• Call Center experience

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Quality Engineer , located in Salt Lake City, Utah.

The Quality Engineer Assist in the investigation and corrective actions of Quality issues related to Customer Complaints, Corrective Action Requests, Quality Improvement Requests and Supplier Issues. Collect, analyze and present Quality data for trending and the development of Quality Performance Indicators. Develop and Evaluate test methods and product specifications. Audit Suppliers in regards to quality issues. Ensure supplier corrective actions are implemented and verified for effectiveness. Track Supplier quality on a monthly / quarterly basis and report to management on quality and regulatory issues on a timely basis. Lead and document design review and risk assessment activities (FMEA) and ensure validations are conducted to the depth commensurate with identified risk.

Requirements include:

• Must poses strong technical writing capabilities and statistical data analysis skills.
• Working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO 13485).
• 3-7 years of Quality Engineering experience in quality systems and control or equivalent engineering experience in the medical device industry in various disciplines, including supplier quality, complaint trending, product design and development, and/or manufacturing engineering.
• Bachelor's degree in Engineering or related field.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Senior Mechanical Engineer , located in Salt Lake City, Utah.

The Senior Mechanical Engineer is responsible for all technical aspects of designing medical devices for manufacturing and market success. Is expected to design new products, improve redesign existing products, develop new manufacturing process, improve existing processes, identify and implement cost reduction projects, specify production equipment and provide support to Maintenance and Manufacturing in technical matters. Must have a strong hands-on approach and aggressive problem solving attitude. Complete various projects, as assigned, related to product, process and equipment development. Establish and meet project schedules Identify costs, and manage financial resources.

Required Experience and Qualifications Include:

• Medical device design, development and manufacturing experience and familiarity with FDA QSR/ISO 9000/ISO 13485 regulations.
• Experience designing products for high volume manufacturing and transferring products into production utilizing high volume injection molding and automated assembly processes.
• Excellent analytical skills and fundamental engineering knowledge including stress analysis (FEA), mechanical design, tolerance analysis, thermal effects, and fluid dynamics.
• Must have a thorough knowledge of thermoplastic and silicone material properties and associated molding processes.
• Experience with design, execution, and analysis of experiments, verification tests, and validation techniques using statistical tools.
• Solid modeling via SolidWorks and experience with ASME Y14.5, ISO, and GD/T principles.

BS in Mechanical Engineering or equivalent, MS or MBA preferred. Management experience a plus. 5-10 years experience in medical device related engineering in a high-speed production environment. Six sigma experience (black belt preferred). PMBOK certification a plus.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical currently has an open position for a Manufacturing Quality Engineer, located in Salt Lake City, Utah.

The Manufacturing Quality Engineer conducts and writes root cause investigations and implements effective corrective and preventative actions for quality issues. Aids in implementing jidoka (quality at the operation) philosophies. Collects, analyzes, pareto data sources to identify potential areas for quality improvements. Performs impact assessments and investigates the identified risks. Revises procedures associated with investigation findings. Assists in the tracking and trending of corrective and preventive actions for plant quality issues to assure timely closure. Responsible to remain current in regulatory expectations and industry practices regarding investigations and CAPA. Serves as an administrator for plant statistical software control programs (Datamyte). Will set up new test equipment for quality inspections. Fills in for quality department supervisors. Aligns quality procedures among various internal and external quality organization.

Requirements:

• Excellent analytical skills and technical writing capabilities
• Proficient in word processing, spreadsheet, and presentation software applications
• Strong oral, written, presentation and interpersonal skills
• Be able to interface with multiple disciplines within the organization
• Ability to organize data from multiple sources, extracting key information and writing technical reports with executive summaries
• Experience using data analysis computer tools and statistical analysis tools

Bachelors degree in engineering science or related field is preferred. Prior experience in quality assurance is preferred. Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.

This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth.

ICU Medical, Inc. is a major international medical device manufacturing firm headquartered in south Orange County, California. We design, manufacture, and market (both domestic and internationally) proprietary disposable medical devices used to protect doctors, nurses, and other healthcare workers and their patients from the accidental spread of infectious diseases. Due to consistent growth and high demand for the best, we are continuing to provide excellent career opportunities for ambitious, career-minded sales professionals eager to work for a successful industry leader. (Candidates can live in Maryland, Washington DC or Northern Virginia.)

In this career position you will work within the expanding infusion therapy market; with medical device manufacturers, and distributors. This position will include calling on acute and alternate site (non-hospital) healthcare locations.

Recent college grads AND sales professionals with 1 to 5 years sales experience are encouraged to apply. Requirements: Candidate must have excellent interpersonal skills and have a drive towards goal achievement; must demonstrate the ability to be a self-starter with a competitive desire to succeed; must be available to travel.

This is an EXCELLENT OPPORTUNITY for an eager and ambitious individual to join our successful team. We offer competitive compensation, travel/car allowance, a solid benefits package, and the advantages of a company exhibiting consistent annual growth.

COVER LETTER is appreciated and will get you increased visibility.