A new, dedicated sustaining function is being created in Neuromodulation, Valencia, California. The charter of this team will be to maintain the design intent of our rapidly growing portfolio of launched products to ensure customers’ evolving expectations and Divisional business strategies are met. This team will enhance product and patient value in changing markets through process and design continuous improvement projects and will minimize product-related interruptions through material replacement, OEM product support and product redesigns. The team is part of the Neuromodulation Research & Development function and will work closely with the Neuromodulation manufacturing sites (in Ireland, Puerto Rico and US) and Global Supply Chain to manage manufacturing related issues and change control.
Monitors launched products, assessing compliance inputs, quality inputs, manufacturing inputs, and business inputs to maintain design integrity & product safety, compliance and quality post-launch.
Identifies and prioritizes strategies and projects for investigation, design, and implementation of new or improved products, processes and/or applications.
Coordinates design transfer activities from new product development to sustaining engineering. Manages design activities & deliverables throughout the life cycle of commercial products.
Management and support of CAPA projects, continuous improvement projects, corporate strategic projects, Operations requests for support, plant moves and acquisitions, ensuring manufacturing continuity.
Enhances performance, supports expanding indications and commercial product release into new markets.
Partners with Operations and Marketing to manage and execute end of life and rationalization activities.
Proactively influences international standards development and ensures commercial products remain compliant to applicable international and local standards.
Ensures implementation of functional excellence initiatives.
Develops and leverages relationships within R&D, manufacturing sites, Regulatory and other key business partners
Develops and maintains sustaining metrics, budgets and schedules.
Responsible for succession planning and the development of team members.
Proactively reviews future technologies and implements plan to acquire or grow resources with appropriate technical skills
Qualifications/Experience/Competencies:
BS degree in Engineering or applicable field required (MS preferred) with at least 12 years technical professional experience
Must have at least 8 years’ experience directly managing people, be able to demonstrate strong leadership skills and have experience leading through change
Must have medical device experience
Working knowledge of product life cycle management and knowledge driven product development principles
Knowledge of CAPA & continuous improvement systems/processes
Must have proven experience launching products –from exploration to launching commercial products
Strong project management experience
Portfolio management and process experience required
Must have experience working with R&D organizations
Demonstrable skills in developing and managing collaborative relationships across functions & locations
Ability to establish, communicate and engage teams in the vision & strategy of the function
Proven ability to create comprehensive and robust talent management plans, talent pools, and bench strength within the organization.
Creates a sense of energy, excitement, and personal commitment to the organization by empowering others, rewarding and celebrating superior performance, and creating an inclusive workplace
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