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Design Assurance Engineer


Requisition Number: P11051

Region: US
State: Wisconsin
City: Hudson

Responsibilities

  • Audit, create, and maintain medical device and combination device Design History Files throughout a staged Design Development Process.
  • Create and execute Design Controls relevant to multiple product categories in a Contract Manufacturing Organization.
  • Provide project leadership with respect to Design Controls, Risk Management, and Design Verification Test Planning for both Medical Device and
  • Combination Device Products.
  • Participate on development teams representing Design Assurance Engineering.
  • Implement, improve and maintain Quality Management System procedures compliant with ISO 13485:2016, ISO 14971:2012, and 21 CFR 820 (specifically 820.30)
  • Supporting Internal, External, and Customer audits as they relate to Design Controls.
  • Coordinate new process techniques that improve overall job efficiencies
  • Extended travel to other Phillips-Medisize facilities, or our customers may be required to support business needs
  • Some programs may have vision requirements
  • Other duties as assigned
  • Safety/Environmental:
       -  Where applicable, individual is pre-planning safety into work activities to improve performance
       -  Proactively identifies safety concerns
       -  Complies with Environmental Management System Program SOP’s/WI, Policy & Program elements and encourages responsible use of resources
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
       -  Completion of one of the following:
            -  Submission of a continuous improvement idea
            -  Active participation in a Phillips-Medisize sponsored committee or event
              (Examples include a - Rapid Improvement Event, a 5S/Lean event, Safety
               Committee, Wellness Committee, Recycling Committee, Activity Committee, or
               other Phillips-Medisize sponsored community outreach project/event (United
               Way, Junior Achievement, etc.)

Qualifications - Education & Experience

  • Bachelor degree in an engineering discipline or equivalent experience, per engineering criteria matrix
  • Minimum six (6) years quality/regulatory experience
  • Minimum three (3) years design assurance engineering or Design Quality Engineering specifically with the management of Design History Files.
  • Medical Device or Combination Device FDA Submission Experience is preferred but not required.
  • Team-centric design experience
  • ASQ certification preferred

Qualifications - Skills & Competencies

  • Demonstrated ability to provide statistical guidance in the sampling activities executed for Design Verification
  • Understanding of design and development processes, associated terminology, and ISO 13485, ISO 14971 and FDA regulated product quality requirements.
  • Ability to effectively present information and respond to questions from managers, sales personnel, and customers
  • Strong communication (verbal and written), teamwork and organizational skills
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve compliance to requirements
  • Demonstrable track record of project accomplishment
  • Demonstrable track record of planning activities with contingency actions

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