Sr. Manager, Design Assurance & Reliability Engineering

Overview

Sr. Manager, Design Assurance & Reliability Engineering

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Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Summary Description

The Senior Manager of the Tissue Technology (TT) Design Assurance Engineering department is responsible for developing Design Assurance Engineering resources, processes, and tools required to design, develop and commercialize best in class TT product offerings. Duties include strategic planning and budgeting for the function, determining skill needs, talent acquisition, adherence to quality processes, performance management, staff 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, Change and Design Controls. Provide guidance to and / or lead project teams by participating in business design, technical and gate reviews.

• Functional Management of the Design Reliability Assurance Engineering Staff of the TT DRA organization
• Lead the design and development of new or improved products in close collaboration with Product Development, Project Management, Regulatory, Marketing, Corporate and Site QA and Medical Affairs.
• Interact routinely with R&D Management on matters concerning engineering technologies and development projects.
• Influence TT Design Assurance functional strategy on matters including core capabilities, product quality, design control processes, resource development and utilization, and engineering practices.
• Work closely with TT 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.
• Set departmental goals based on corporate and divisional initiatives.
• 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 and remediation objectives.
• Identifies and solves complex, operational and organizational issues, leveraging the appropriate resources within or outside the department.
• Work with CSS leaders and quality assurance stakeholders to unify processes and tools (where possible) to enable common work practices between the CSS and TT Divisions.

• Drive Technical and Process Excellence
• Influence the continuous improvement of the product development process to ensure quality, robust work products via metrics and design assurance processes.
• Ensure the application of best practice design assurance engineering methods to produce robust design solutions.
• Drive cross project standardization and maximize component reuse.
• Influence the selection of appropriate technology, technology and development partners to ensure project success.
• Ensures compliance to Integra Life Sciences quality standards and conveys an expectation of high product quality.

• Apply Design Assurance Expertise in a Leadership Role
• Lead or participate in design, technical and gate reviews.
• Thoroughly assess the ability of proposed designs to meet specified requirements.
• Plan and lead technical design assurance activities from concept through successful commercialization, and continuous product improvement within established schedules, budgets, and product cost targets.
• Provide technical assessments of existing products for consideration in new product development.
• R…