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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)
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)