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)