Colorado Engineering Jobs

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Maquet Cardiovascular Engineer Process/Validation in Englewood, Colorado

Steritec Products Inc., a member of the Getinge Group, manufacturessterilization and cleaning medical device consumables using ink technology. Wemanufacture and print highly specialized proprietary inks that undergospecific color changes when exposed to different sterilization conditions inhospital and industrial/pharmaceutical sterilizers.Job Function Summary:Assists with current processes, and development of new processes in supportof RandD, Manufacturing and Product Development. Provides support andguidance on validation activities related to manufacturing/test equipmentand processes.Primary "essential" Duties and Responsibilities:* Works to improve efficiency and effectiveness of manufacturing and otherfacility processes.* Provides Process Design Engineering guidance to RandD, Manufacturing andProduct Development.* Assists with process flow documentation and design including processsteps, workflow and material handling techniques.* Assists with applying statistical analysis techniques.* Assists with RandD protocols for new product introduction.* Provides input to new equipment designs with emphasis on concurrentengineering and improved productivity techniques.* Assists with process documentation generation and maintenance.* Participates in new equipment qualification and validation.* Participates in process and test method qualification and validation.* Assists in special projects as needed.* Contributes to team effort by accomplishing related duties as requested.Required Knowledge, Skills and Abilities:* Successful project management experience is required.* Experience in problem solving and troubleshooting using statistical andanalytical tools required.* Excellent communication skills, ability to work in a team environment andability to lead a project team.* Demonstrated knowledge and application of Lean concepts preferred.* Demonstrated creative problem solving in a regulated manufacturingenvironment.Minimum Requirements:* Bachelor's Degree in Engineering, or equivalent.* Minimum three years progressive experience in a medical device environment.* Experience in analysis of manufacturing processes, development of processimprovements and validation of process changes desired.* Knowledge of statistical techniques and sampling for process validation andprocess monitoring is desired.* Basic computer skills including word processing and spreadsheet experiencerequired.* Strong MS computer skills including MS Office Suite (Word, Excel) arerequired.* Working knowledge of Minitab preferred.* Experience with Agile PLM or other documentation management system desired.Environmental/Safety/Physical Work Conditions:* Ensures environmental consciousness and safe practices are exhibited indecisions.* Duties are mainly performed in an office environment.* Duties may be required to be performed in a controlled environment followingspecific gowning procedures.* May work extended hours during peak business cycles.* The individual must occasionally lift and/or move up to 15 lbs.* Ability to utilize computer and telephone equipment and other related officeaccessories/devices to complete assignments.* While performing the duties of this job, the employee is frequentlyrequired to stand, walk and sit.* The employee must have use of hands to finger, handle or feel objects,tools, or controls; reach with hands and arms; speak and hear.* Specific vision abilities required by this job include close vision,distance vision, color vision, peripheral vision, depth perception andthe ability to adjust focus.The physical demands described here are representative of those that must bemet by an employee to successfully perform the essential functions of thisjob. Reasonable accommodations may be made to enable individuals withdisabilities to perform the essential functions.Internal and External Contacts/Relationships:* Internal: Team members (including contractors), all Getingecolleagues including the executive and leadership team, Finance,Purchasing, Quality