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)