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Manufacturing Systems Engineer - 53153396 - TT

Job Code: 53153396
Job Location: Fridley, MN
Category: Manufacturing Engineer
Last Updated: 09/27/2016
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Job Description:
To provide systems engineering support for the design and development of a hemodialysis system for through technical planning, system level evaluation, verification and validation. To provide engineering expertise on cross-functional development project teams.  
Main Job Duties/Responsibilities:
Lead risk assessments at the patient hazard level, the detailed design level, and from a human factors perspective
• Translate risk mitigations and safety needs into system/subsystem requirements and/or product design performance targets.
• Ensure that device development plans meets targeted clinical application through systematic conversion of product requirements into systems solutions that acknowledge technical, schedule, and cost constraints.
• Generate specifications for the product; ensure that all systems are developed in harmony and support each other.
• Establish system verification and validation plan(s)
• Plan and execute system level verification and validation through pre-clinical evaluation.
• Apply established SOP's, and/or develop new processes as needed, to ensure that newly developed devices meet established requirements
• Assess system performance during the development process and provide feedback to the team
• Collaborate with quality and regulatory colleagues to ensure compliance
• Participate in the identification and resolution of complex system issues through interfacing with engineers representing other components
• Develop technical briefs evaluating technical tradeoffs and proposing a pathway forward.
• Evaluate device use cases to define system requirements and evaluate technical tradeoffs.
• Participate in product risks assessment and develop mitigation plans to ensure safe operation of the product
• Participate in the software development for an electromechanical medical product
• Coordination with external design partner of software and hardware integration into an electromechanical medical product.
• Work with System Architect Engineers to develop use case analysis, documentation and approve uses cases.
• Develop use cases for the fluid circuit, alarms, and process flow for a hemodialysis system.
• BS in BM, EE, or ME
• 10+ years of related experience
• Experience developing system from concept  
• Strong written and verbal communication
• Attention to detail, thoroughness
• Able to work in direct, cross-functional and cross-cultural teams
• Strong organization and time management skills; ability to manage multiple priorities
• Self-starter, strong work ethic and initiative in accomplishing objectives DESIRED/PREFERRED QUALIFICATIONS
• Work experience developing or testing liquid fluid circuits, including fluid mechanics, fluid filtration, fluid metering, flow control and fluid connectors; heat transfer; fluid measurement and sensing.
• Medical Device development experience
• Hemodialysis experience
• Experience developing software and hardware.
• Highly skilled at delivering in an ambiguous environment.
• Entrepreneurial spirit.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53153396TT
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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