System Engineer

 
Location: Minneapolis, Minnesota
Posted On: 5/8/2017
Job Code: 3097_SE_MN
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Job Description
 
Position description:
• This is a Systems Engineering position within in the RTG Implantable Product Development organization.
• We are looking for individuals who have a strong background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation.
• The ideal candidate would be someone with relevant educational and/or demonstrated experience maturing complex systems with significant electrical components.

Position responsibilities:
• Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively.
• Authors a system level Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage.
• Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity.
• Executes tests per defined Integration Plan.
• Works with various stakeholders to understand scope of characterization needed, including need to understand design capability.
• Executes system characterization efforts.
• Influence product/component integration and characterization plans in order to assist in incremental system maturity.
• Works with engineers in various functional departments to achieve results.
• Authors design verification and design validation protocols and reports.
• Executes system verification and validation activities.
• Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study.
• Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study.
• Plan and execute Test Method and Non-product software validation, and equipment and tooling qualification, per project needs.
• Monitors progress of assigned tasks to defined project schedule.
• Produce high quality deliverables while complying with relevant SOP.
• Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval.

Basic qualifications:
• 7+ years of job-related experience with a Bachelor’s degree; or 5+ years of job-related experience with a Master’s degree.

Desired/preferred qualifications:
• Bachelor's or Master's Degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, Reliability Engineering, or Mathematics.
• Experience in engineering and testing mission critical systems and/or medical device systems.
• Demonstrated experience maturing System with significant electrical component.
• Experience working with detailed requirements and traceability in order to author test plans, protocols, and reports.
• Experience working in cross-functional team effort.
• Demonstrated strong verbal/written communication and influence management skills.
• Proven ability to accomplish critical project level objectives in a team environment.
• Knowledge of or experience working with Systems Engineering principles.
• Knowledge of or experience working in a regulated and/or FDA medical device environment.
• Knowledge of or experience working with ISO and Quality System Regulation requirements.

Physical job requirements:
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to work for extended periods of time at a computer.
• Ability to sit/stand/bend for up to 8 hours a day.
Category:IT  code:new
 
 
Job Requirements
 
 
System engineer, System engineering, Medical device/instrument/equipment, FDA medical device environment, ISO and Quality System Regulation requirements
 

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Contact Details
 
Recruiter
Nikunj Patel
 
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