Senior Manager, Design Assurance

About the position

The Senior Manager, Design Assurance, is responsible for creating the strategy and systems required to support the New World Medical product life cycle from product concept to end of life. The Senior Manager, Design Assurance, will design quality assurance systems and processes for new products or modification of existing products. Will support the Research and Development, Sustaining and Production teams and improve customer satisfaction through more efficient and structured product development methods.

Responsibilities

• Establishes and controls process and budget for department.
• Leads operational efforts through direct reports, constructs strong framework of knowledge and processes with the intent of building a robust design control system.
• Aids improve speed to market, reduction of risk to patients, regulatory compliance, and continuous quality improvement with the goal of reduction in overall post market issues.
• Assures reliability targets and testing are appropriately implemented, suitable quality tools are deployed and utilized on projects, the appropriate level of design verification and validation activities are performed, and project schedules are met.
• Reviews change requests related to design change and process change with regards to proper design control and quality engineering application.
• Assists with review of the development process and development of engineering deliverables to support a compliant and high-quality design, use, delivery, and maintenance of the product.
• Assists with identification of possible design deficiency as early as possible in the design life cycle and determining the adequacy to meet regulatory requirements and engineering design safety and efficacy of products to increase the likelihood that the design meets or exceeds reliability requirements, regulatory requirements, and customer expectations.
• Responsible for managing design assurance function including talent acquisition and budgets.
• Oversees technical performance of Quality Engineers on assigned project activities.
• Deploys and utilizes staff across a wide variety of research, product concept, and development activities.
• Provides leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce.
• Acts as technical expert in Quality Engineering and Design Control to staff and project teams.
• Ensures regulatory requirements compliance related to design and verification and validation activities.
• Serves as technical reviewer for projects, performs preliminary and critical design reviews, as appropriate, reports issues related to project technical performance.
• Develops effective cross-functional relationships with research and development, sustaining engineering and site management to meet departmental and organizational goals.
• Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization.

Requirements

• Experience developing and managing teams.
• Experience managing and implementing multiple projects in exemplary fashion.
• Excellent presentation, written and verbal communication skills.
• Strong time and project management skills with attention to detail and the ability to plan and prioritize work and balance multiple projects.
• Capable of cross collaboration with other departments and providing strategic insight that indicates an enterprise mindset.
• Ability to build effective working relationships across functional areas and levels of the organization.
• Proficient in Microsoft Office Suite and Adobe.
• Working knowledge of ISO And FDA regulations.
• Bachelor’s degree in a Science or Engineering discipline required. MBA preferred.
• 7+ years of experience, preferably in medical devices.
• 4+ years of managerial experience.
• Minimum 3+ years of project management experience, preferably in new product development.

Benefits

• Medical, Dental, and Vision Insurance
• 401(k) with Profit Share
• Bonus Opportunities
• Flexible Work Schedules
• Free Onsite Daily Lunches to foster team connection
• Career Development Program
• Tuition Assistance (after 1 year of service)
• Cell Phone & Home Office Stipends
• Wellness & Employee Assistance Programs
• Company Events & Recognition
• And more!