Design Assurance Engineer - Contractor

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This is a temporary contracted position.

This position leads quality engineering activities for development projects from conception to commercialization, including development of the risk management file, completion of DHF deliverables, and significant involvement in design verification/validation. This position is also responsible for quality engineering activities to support design changes for commercial products. Through these activities, the Design Assurance Engineer II will verify the quality, reliability, and compliance of mechanical product designs.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• Drives mechanical product design quality, reliability, and compliance to standards and regulations
• Leads and supports on-time completion of design control deliverables
• Critically evaluates mechanical product designs, identifies potential design quality issues, and drives issue resolution
• Leads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization
• Develops release testing plans for new products
• Leads DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Supports quality system development and improvements
• Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Supports print specification definitions, development, and changes
• Supports design test and inspection method development and validation
• Supports design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations
• Supports and ensures on-time execution of Quality Plans for OEM manufacturing for development projects and design changes
• Supports manufacturing process development & qualification for new product commercialization and product changes
• Supports internal & external audits
• Supports complaint investigations
• Supports significant investigations related to product quality for commercial products as needed
• Responsible for maintaining a strong collaborative partnership with cross-functional team members and partner organizations that facilitates organizational success by protecting patient/user safety and meeting business needs
• Perform other related duties as assigned
  
  

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
• 3 years relevant experience within the medical device industry or related function
• An equivalent combination of experience and education may be considered
  
  

Other skills and abilities:

• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred
• Strong statistical data analysis skills
• Ability to manage multiple projects
• Excellent verbal and written communication skills
• Able to work independently as well as in a cross-functional team environment
• Ability to educate stakeholders, customers, suppliers, and management
• Customer focused and service oriented
• Acts on their strong desire to make a difference, partner with others and put ideas into action
• Be engaged by a work culture that is team-oriented, fast paced and progressive
  
  

Preferred/Beneficial:

• Design for Six Sigma and Critical to Quality training and experience
• Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs
• Experience partnering with external organizations (customers and suppliers) to complete projects
• Experience with participation in audits
• ASQ certification
  
  

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