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Senior Design Assurance Engineer

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Regulatory & Quality Assurance
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3703 Total Views
Thanks for your interest in the Senior Design Assurance Engineer position. Unfortunately this position has been closed but you can search our 296 open jobs by clicking here.
Qualifications  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

 
  • Skilled in requirements analysis, including testable and measurable specifications
  • Experience with test methods and standards for the design, verification, and validation of medical device products
  • Skilled in test plan development and root cause failure analysis
  • Familiar with reliability analysis and test methods and test method validation
  • Working knowledge of IEC60601, IEC62366, EN62304
  • Good verbal (including presentation) and written communication skills, especially technical report writing
  • Ability to effectively work on project teams
  • Ability to appropriately assess written design and device documentation as the principle advocate for compliance
Preferred Skills/Qualifications:
  • Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Working knowledge with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
  • Skilled in statistical methods and design of experiments
  • Manufacturing engineering or manufacturing quality engineering experiences a plus
 
 
Education  
  • BS in an engineering discipline
 
Experience  
  • 3-5 years of engineering experience, preferably with V&V system/software validation
  • Strong working knowledge of verification and validation in a regulated industry
  • Experience with test methods and standards for the design, verification, and validation of medical device products
  • Skilled in test plan development and root cause failure analysis
 
 
Agency and Third Party Recruiter Notice:
 

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor

 
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