Senior Design Assurance Engineer

1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Senior Design Assurance Engineer

  • Specialty:

    Engineering
    • City:

      Eden Prairie
    • State:

      MN
    • 55344
  • Assignment Type:

    Direct Hire
  • Job Id:

    54211
  • Payrate:

    $52.88

Description

The DAVIS Companies has partnered with a leading, growing Medical Device company to identify a Sr Design Assurance Engineer to join their team! This role is ideal for someone that is looking to make a major impact and influence organic growth of the business! 

The Senior Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of product/process development and input to Quality Management Systems affecting product/process development. Champions departmental or cross-functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices.

Essential Responsibilities of the Sr Design Assurance Engineer:  

  • Key member of medical device development project teams to ensure compliance to Design Controls requirements.
  • Responsible for quality activities and deliverables on the cross-functional development team.
  • Responsible for strategic quality planning activities on the project, including PMS planning.
  • Assures that proper controls are established to meet or exceed internal and external requirements.
  • Cross-functional leader for completion of Risk Management deliverables.
  • Partners with Regulatory development project team members to summarize or generate information to be supplied to Regulatory Agencies
  • Utilizes problem solving methodologies to lead failure investigation activities to ensure root cause is identified and proper controls are established.
  • Leads design verification, design validation, usability and test methods validation activities for new product development to meet or exceed internal and external requirements.
  • Coaches and mentors product development team on Design Control activities.
  • Drives consistent quality engineering practices among DA team members
  • Responsible for impact assessment and integration of Quality System changes into project execution.
  • Ensures quality system compliance and primary team contact for audits.
  • Surfaces Quality System issues/gaps to appropriate organization level. 

Requirements of the Sr Design Assurance Engineer: 

  • BS or MS degree in Engineering
  • 5+ years overall medical device experience
  • 5+ years experience in R&D space 
  • Expert knowledge of Design Control and Risk Management
  • Knowledge of Problem Solving methodologies and approaches
  • Experience with Quality Systems as outlined in CFR820/ ISO13485
  • Experience with leading CAPA investigations and developing effective corrective actions that utilize a risk based approach
  • Demonstrated technical expertise and leadership in quality
  • Demonstrated use of Quality tools and methodologies
  • Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)

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Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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