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Design Assurance Manager

Design Assurance Manager

MediabistroMinneapolis, MN, United States
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Our mid-sized medical device client is adding a Design Assurance (DA) Manager to the team. The DA Manager will be responsible for providing quality engineering support for all phases of product development, driving post-market assessment activities, and supporting consistent design through production release and commercialization.

Your role with the company :

Responsible for ensuring staffing and successful execution for all projects assigned to the DA team. Serve as a working team member in the execution of product development process (PDP) deliverables for complex projects. The DA manager will own development / improvements for procedures in the areas of Design Control and Risk Management and serve as a corporate-wide SME, major contributor and key influencer on Design Controls, Risk Management and Post Market Surveillance activities.

Management

Develops and maintains a solid team environment through effective hiring, communication, recognition, feedback and development

  • Working manager that both manages the team and serves a design assurance function for assigned teams or projects
  • Monitors, directs, and prioritizes staff workload to ensure business objectives are met
  • Contributes to establishing overall Quality department yearly goals and objectives
  • Advises planning for department resource needs
  • Responsible as primary interface for internal audits, regulatory body audits for responsible areas
  • Determine appropriate staff levels and schedules while working with key partners to understand priorities and plan resource allocation accordingly
  • Provides mentoring and coaching for less experienced staff

Product Development Team Member

  • Serve as DA Lead (Core Team member) on cross-functional PDP team
  • Provide subject matter expertise and leadership in the area of Design Controls and Risk Management
  • Understand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologies
  • Lead execution of risk management activities for PDP projects
  • Develop Design Verification, Design Validation, and Usability plans, protocols and reports
  • Develop and execute or oversee test method validations
  • Plan post market activities for the project through development of PMS Plan, Field Assessment Plan and support of Clinical Evaluation, clinical literature review and PMCF studies
  • Understand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies.
  • Lead problem solving activities, failure investigations, and CAPA activities
  • Support design transfer activities including process validation and material qualifications.
  • Serve as project manager for the project or specific area of the project, if requested.
  • Provide subject matter expertise for assigned projects in audits
  • Balance complex performance, regulatory, and manufacturing requirements to achieve most optimal solution for the project.
  • Post Market

  • Lead planning and facilitate execution of post market surveillance activities
  • Lead complaint investigations in the categories of risk assessment investigations
  • Generate Field Assessment and Post Market Surveillance reports
  • Analyze engineering change requests
  • Support process and design change activities
  • Address regulatory standards gap assessments to maintain product compliance
  • Quality Systems

  • Drive improvements to the design control, post-market surveillance, risk management, and any other assigned processes to ensure ongoing compliance
  • Develop and maintain key quality metrics and drive improvements
  • Develop risk-based procedures and instructions throughout the quality system
  • Present trending data to management during management review
  • Review current regulations and requirements and recommend changes to quality system
  • Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs
  • Desired Profile :

  • BS or advanced degree in technical discipline, engineering preferred
  • 3+ years management experience
  • 8+ years overall medical device experience
  • 8+ years' experience in DA
  • or Quality Engineering function

  • Extensive experience with QSR and ISO regulations
  • Extensive experience with statistical techniques, measurement / trending and SPC tools
  • Demonstrated technical expertise and leadership in Quality
  • Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment
  • Self-starter, with the ability to manage multiple tasks and tight timelines
  • Demonstrated use of tools and methodologies within a Quality System
  • Proficient computer skills- Microsoft Word, Access and Excel, statistic software (jmp, minitab)
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    Design Manager • Minneapolis, MN, United States

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