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Fresenius Medical Care North America Software Engineer II in Ogden, Utah

Job ID 200000TA

Available Openings 1

PURPOSE AND SCOPE:

Supports the plant software projects and software validations of new equipment. Provides software services for the assigned plant manufacturing and performs software validations and backing up process validations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Develops, tests and implements hardware/software of new technology to obtain manufacturing enhancement to improve processes.

  • Maintains good documentation practices.

  • Establishes and/or revises validation protocols, SOP's, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports.

  • Writes project proposals, equipment specifications, operating procedures and test methods.

  • Performs corrective and preventative actions.

  • Assists in training of production and maintenance staff on new equipment and software applications or improvements.

  • Assist department staff in troubleshooting process problems.

  • Maintains compliance with all state and federal regulations, SOPs and company policies

  • Maintains general housekeeping of working area and plant.

  • Self-motivated to improve knowledge related to process and sterilization validation techniques by continuous assessment of current publications, standards and regulations.

  • Builds productive working relationships.

  • May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.

  • May refer to senior level staff for assistance with higher level problems that may arise.

  • Escalates issues to supervisor/manager for resolution, as deemed necessary.

  • Assist with various projects as assigned by direct supervisor.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Frequently required to stand; walk; sit and talk or hear. Occasionally required to use hands and fingers, handle or feel, reach with hands and arms; stoop, kneel, or crouch, and wear personal protective equipment that may include safety shoes, safety glasses, hearing protection, hair net, face mask, smock, hard hat, Solution bunny suit, chemical resistant gloves, cut gloves, etc.

  • Regularly lifts and/or move 10 to 25 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 100 pounds with assistance.

  • Frequently exposed to moving mechanical parts. Occasionally exposed to fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock.

  • The noise level in the work environment is usually moderate.

EDUCATION :

Bachelor’s Degree in engineering or other technical fields required

EXPERIENCE AND REQUIRED SKILLS:

  • 2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience.

  • Must be able to prepare clear and informative engineering and technical reports with accuracy.

  • Skilled in logic controller programming, Human Machine Interface programming or higher levels of code are required.

  • Fundamental knowledge of PLC software development language and programming principles.

  • Proficient with PCs and Microsoft Office applications.

  • Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, validation protocols and reports, operating instructions, schematics, blueprints, general business periodicals, or governmental regulations.

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

ADDENDUM:

Sterilization focus

  • Proficiently performs testing and evaluation of process validations, various sterilization validations, and software validations in compliance with all Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualification (PQ), software development and product design.

  • Assist in sterilization validations/requalification.

  • Complete/review sterilization process cycle reviews or irradiation certifications as assigned.

  • Expertise in electrical, electronic, pneumatic, heating/cooling systems, mechanical operations, and pressurized systems.

  • Ability to develop, test and evaluate hardware/software systems and their functions. Designs flow diagrams, update schematics, process drawings, and provide recommendations as support of improvements to sterilization vessels or process.

  • Provide technical support by responding to inquiries regarding errors, problems, or questions about sterilization software used by other departments.

  • Maintains inventory of software required in operating computers for Human Machine Interface(HMI) and PCLs other than those controlled by IS. Loads and updates software applications as required. Recommends or designs sterilization software technologies, to make the company more efficient.

  • Maintain back up of process records for steam sterilization and operation process parameters.

Dialyzer focus

  • Maintains current system automation and new control systems with regard to: software PLC programming, electrical hardware, and new design implementation, documentation of new software projects and equipment upgrades of control electrical systems.

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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