Entegee Manufacturing Systems Engineer - 53153396 - TT in Fridley, Minnesota
Manufacturing Systems Engineer - 53153396 - TT
Job Code: 53153396Job Location: Fridley, MNCategory: Manufacturing EngineerLast Updated: 09/27/2016Apply Now!
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
SPECIALIZED KNOWLEDGE REQUIRED
• 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 firstname.lastname@example.org.
Please reference job # 53153396TT
Equal Opportunity Employer