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141372- TECHNICIAN II - 53443923 - AD

Job Code: 53443923
Job Location: Brooklyn Park, MN
Category: Technicians
Last Updated: 09/29/2016
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Job Description:
Perform a wide variety of non-standard complex duties in a multi-functional area requiring judgment in methods and ability to interpret test results. Perform testing and failure analysis to identify failure modes and identify process variations/challenges. Recommend improvements in manufacturing processes. Assist with implementation of process changes to maintain lean production by evaluating value stream contribution and effect on final products. Possess strong problem solving skills and thorough understanding of a variety of manufacturing equipment and components. Provide sustaining production line process support. Perform validation and qualification activities for packaging/sealing equipment and process. Investigate and resolve work-in-process problems. Collaborate with packaging engineering, quality engineering and manufacturing operations in above activities.
Position Responsibilities:
• Partner with Manufacturing Engineering to determine test plans for process characterization and/or qualification, get proper signoffs and perform processes evaluations or conduct tests from detailed instructions to identify process variation.
• Identify and understand process parameters in order to develop/design test procedures from concept or process description.
• Define and generate required documentation in support of manufacturing processes. Ensure compliance with GMP’s and internal protocol.
• Assess device, process or material performance against standards or specifications such as impact to output and troubleshoot problems by identifying the sources of the problem and recommend steps to rectify it.
• Interpret results, evaluate for trends and write and/or present clear, accurate reports of findings.
• Continuous Improvement and Cost Analysis: Continually improve manufacturing methods and systems using Lean Enterprise philosophies to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement inherent in manufacturing processes and make specific recommendations for adoption.
• Lead troubleshooting activity on machines and equipment used for product manufacturing and maintain or improve FMEA (Failure Mode & Effects Analysis) rating for any process involved.
• Provide training to personnel within/outside immediate functional area in the functional activities of the group.
• Perform special analytical processes from non-detailed instructions.
• Participate on cross-functional, cross-site project teams focusing on packaging process technology, process improvements
• Develop technical documentation including Installation Qualifications, Process Characterization, Operational Qualifications, and Process Qualification protocols and reports, associated with the qualification and release
• Analyze and interpret test results for packaging components and assemblies
• Participate in trouble shooting and problem solving of equipment and process issues
• Establish preventative maintenance plans and schedules
Basic Qualifications:
• 2 year technical degree (Manufacturing, Packaging, Industrial, Mechanical discipline)
• 4 years hands on experience in a manufacturing environment
• Ability to work with automated equipment in a clean room environment
• Ability to work with close dimensional tolerances
• Experience in a GMP regulated environment
• Exposure to complex problem solving and judgment with implementation of permanent corrective actions
• Statistical methods and analysis
• Proficiency in computers. Experience with Excel, Minitab, Word, Outlook
• Clear, concise and accurate written and oral communication
• Ability to follow written and verbal instructions
• Well-developed organizational and planning skills
Desired/Preferred Qualifications:
• 6+ years hands on work experience in a manufacturing environment
• Experience in a medical device manufacturing
• Lean Six Sigma/Green Belt with a preventive mindset
• Self-motivated/Takes initiative/Customer responsive
• Working knowledge of MS Project, Agile (or other PLM/Data Management System)
• Experience with developing fixtures/tools and with automated packaging equipment/processes
• Flexibility in day to day activities and use of good time management skills
• Knowledge of ISO and ASTM standards and test methods related to packaging
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53443923AD
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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