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Principal Systems Engineer

Deerfield, Wisconsin

Post Date: 08/08/2017 Job ID: 1578 Job Category: Healthcare

The Principal Systems Engineer is responsible for the primary definition (specs) and architecture (systems design) of AED products.

 

Essential Responsibilities: 
  • While working with Marketing, develop the Product Design Inputs (PDI) that describe the system level requirements for a device. 
  • Develop or oversee lower level specifications (Module Design Inputs) that define the product.  
  • Create a complete requirements cascade that links all requirements from the PDI down to the BOM.  Forward and Backward traceability.  Participate in and oversee statistical capability analysis both internally and externally to assure development goals are sustainable long-term.
  • Assess verification testing to determine successful completion or assist with re-designs / re-tests / regressions as required.
  • Monitor detail designs with Design Engineering to assure designs meet MDI / PDI requirements
  • Interact with other team members, external consultants, partners, and clients at clinical and/or technical levels. 
  • Comply with company policies and procedures regarding Employee health, safety, and conduct.

 

Required Qualifications:
  • A Bachelor of Science degree in EE, SW or Biomedical Engineering
  • Minimum of 5 years in medical product development environments
  • Hands on skills in requirements cascade / traceability.   
  • Strong communication skills
  • Expert level competency in Microsoft Office suite
  • Expert level competency in requirements cascade software (DOORS or other)
  • Basic understanding of Six Sigma methodology and associated statistical analysis

 

 

Desired Qualifications:
  • AED industry knowledge
  • Medical Device industry experience including FDA Class 3 Pre-Market Approval (PMA) processes and similar requirements for other countries (e.g. IEC standards and technical file requirements   for CE mark).
  • Experience with tools for data analysis and algorithm development like MATLAB

 

Travel:  Less than 10%

 

Working Conditions:

The physical demands and work environment characteristics described here 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.
  • Physical demands: While performing duties of job, employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Employee must occasionally lift and/or move up to 25 pounds.
  • Work environment: The noise level in the work environment is usually moderate.

Colleen Eddy
Senior Recruiter

Colleen brings high energy and a focus on service to her role as Senior Executive Recruiter at The Steely Group. She believes regard for others begins by actively listening to understand which, in turn, builds trust (the bedrock of relationships). Throughout her distinguished career, Colleen has demonstrated success developing talent; building, leading and managing teams; recruiting, training and mentoring executives; and helping employees embrace change and achieve goals.
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