Validation & Verification Engineer

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embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visitembecta.comor follow our social channels onLinkedIn,Facebook,InstagramandX.

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• Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products and changes to existing products.
  
• Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents.
  
• Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validation
  
• Authors design verification protocols to satisfy product design inputs/system requirements, that satisfy applicable Quality System (QS) and regulatory requirements
  
• Manages and tracks product configurations through design verification and validation
  
• Performs hands-on and simulated testing for design verification and test method developments
  
• Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications
  
• Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)
  

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• Minimum of Bachelor’s degree in Engineering
  
• 3+ years of professional experience in the medical device, pharmaceutical or life sciences field.
  

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• Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), etc.)
  
• Experience with executing Design Verification
  
• Experience in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing
  
• Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
  

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• Disciplined and well organized
  
• Excellent multi-tasking, analytical, communication, and prioritization skills.
  
• Ability to work independently with minimal supervision as well as in a team environment
  

embecta is an Equal Opportunity/Affirmative Action Employer. xcfaprz We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

• Entry level

• Full-time

• Quality Assurance

• Medical Device