About the job
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:
Ø 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 between CSS and TT Divisions
Ø Drive technical and process excellence
§ Influence the continuous improvement of the product development process to ensure quality, robust development 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 partners and development partners to ensure project success
§ Ensures compliance to Integra LifeSciences quality standards and conveys an expectation of high product quality
Ø Apply Design Assurance Engineering expertise in a leadership role.
§ Lead or participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements.
§ Plan and lead technical design assurance activities of complex systems and software 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
Ø 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
§ Directly apply design assurance and reliability engineering expertise and experience to execute project assignments
MINIMUM QUALIFICATIONS:
KNOWLEDGE AND SKILLS:
Ø Work experience in an FDA/ISO-regulated environment preferred
Ø Excellent interpersonal communication skills - verbal, written, and listening
Ø Demonstrated understanding and usage of Microsoft Project
Ø Demonstrated experience with Configuration Management tools (source code control, defect tracking, etc)
Ø Talent management skills including coaching and mentoring, dealing with conflict. Manage performance and drive achievement. Recognize and deals effectively with low performance. Ability to recruit, hire, and maintain high caliber staff.
Ø Demonstrated leadership skills driving product enhancement and improved reliability projects.
Ø Demonstrated strong project management skills utilizing agile development practices
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
