Principal Systems Engineer

The Principal Systems Engineer is responsible for the primary definition (specs) and architecture (systems design) of AED products.
+ 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.
+ 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
Cardiac Science is an Equal Opportunity Employer - Minorities/Females/Veterans/Disabled
ID: 2829 3771ce65ac464364b2bdeb63b54a3afc

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