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JOB SUMMARY:

The Manager of the Design Assurance Engineering department is responsible for developing Design Assurance Engineering resources, processes, and tools required to design, develop and commercialize best in class clinical and surgical instruments inclusive of embedded and application software. Duties include strategic planning and budgeting for the function, determining skill needs, talent acquisition, adherence to quality processes, performance management, associate development, and allocation of resources to meet dynamic business needs. Provide technical leadership, assessing technology and industry trends to improve performance in key focus areas such as Risk Management, Product Usability and Design Controls. Provide guidance to and / or lead project teams by participating in function and business design reviews.

DUTIES AND RESPONSIBILITIES :

• Functional Management of the Design Assurance Engineering Staff of the CSS Design Assurance and Reliability Engineering organization.

• Interact routinely with R&D Management on matters concerning engineering technologies and development projects

• Influence CSS Design Assurance functional strategy on matters including core capabilities, product quality, design control processes, resource development and utilization, and engineering practices.

• Work closely with CSS Engineering Managers to establish and align Design Assurance department level plans and objectives with business and R&D strategic plans and objectives

• Identify talent and hire associates with the capabilities needed to meet the department objectives

• Assess and manage performance and development of associates within the group on an ongoing basis

• Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship

• Provides input into yearly budget planning and ongoing resource planning

• Define the engineering capabilities required to meet new product development objectives

• Work with CSS leaders and Quality Assurance to unify processes and tools (where possible) to enable common ways of working across Divisions

• Drive technical and process excellence

• Apply Design Assurance Engineering expertise in a leadership role.

• Collaborate with other technical disciplines and across business functions to develop and meet project objectives.

• Form effective working relationships with cross-functional leaders and teams to deliver complete product solutions to the market. Engage with R+D, Marketing, Service, Quality, Regulatory, Planning and Procurement and Manufacturing groups to understand requirements of stakeholders and customers.

• Interact closely with software, mechanical, systems, and electrical engineering disciplines to develop comprehensive solutions to design problems.

• Provide high-level technical assessments and communications to functional leadership

• Guide Design Assurance team members to evaluate and apply good practice engineering principles to meet project objectives

• Participate in project planning and drive execution to meet project timelines and deliverables

EDUCATION AND EXPERIENCE:

• Requires a BS degree in Science, Engineering, Mathematics, Physics or a related Engineering discipline or equivalent with a minimum of 10 years of industrial experience

• Requires a MS degree in Science, Engineering, Mathematics, Physics or a related Engineering discipline or equivalent with a minimum of 8 years of industrial experience

• Minimum of eight years of experience in product development, product realization, design transfer, design verification and validation

• Minimum of five years leading engineering product development teams

• Minimum of five years of experience in a complex development environment

• Minimum of three years of work experience in a regulated environment