General Summary
The Director, Product Transfer and Project Management position establishes, implements, and directs objectives, requirements, standards, practices, and procedures required to support commercialized products globally while leading global cross-functional project teams to achieve significant business objectives. This scope includes manufacturing line support, component end of life management, new product development, quality and compliance improvements, device transfers, and cost reductions. Responsible for ensuring all production systems, quality standards, safety standards, personnel systems, financial systems, and any other facility administrative system required to support device manufacturing, internally or externally, are in place and functioning at the required quality, compliance, and financial expectations. Coordinates closely with Global Logistics, Supply Chain, Procurement, Research & Development, Quality, and Manufacturing to develop and execute strategies to achieve business objectives. Leads multiple large-scale projects required to achieve business objectives that may include product transfers, quality system improvements, site closures, supplier improvement, field performance improvements, and other subjects as directed.
Essential Job Functions
· Responsible for the overall management and direction of site level sustaining engineering to achieve quality, compliance, and financial objectives.
· Specific to device transfer projects, dotted reported line responsibility of dedicated supply chain, procurement transfer resources, and other functions as appropriate.
· Specific to site closure projects, dotted reported line responsibility of dedicated quality system resources and other functions as appropriate.
· Ensures that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of transfer planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods.
· Maintains open communications with Cross Functional Teams to set and execute key business projects that may be both local and global in scale.
· Collaborates with Design Quality Assurance and Quality Systems to ensure implementation of quality goals and objectives for transfers.
· Recommends alternative methods and procedures for resolving manufacturing problems / issues that may arise.
· Reviews technical problems and procedures of assigned projects and recommends solutions to problems.
· Sets a vision which supports the global growth strategy, profitability objectives and customer requirements; and establish the necessary strategic imperatives which enable that vision.
· Provides leadership in supporting a quality management system which embraces continuous improvement and employee engagement.
· Provides functional global strategy to guide the daily execution, performance improvement and career development of reports.
· Establishes and implements global transfer strategies to support evolving business requirements and global supply chain strategies in partnership with Procurement, Regional Sales Management and Strategic Business Unit Management.
· Establishes and manages an operating system to oversee activities that are critical to the short-term and long-term success of the business and achieve key performance indicator goals.
· Ensures both internal and EMS production lines are sized, designed and staffed properly, in line with future requirements spanning volume, handling, storage, shipping and value-added service.
· Creates long-term and short-term financial projections and key performance indicators.
· Delivers results that meet or exceed the operating plan objectives.
· Acts with absolute integrity and professionalism and ensure integrity and compliance (financial, legal and regulatory) within the region.
· Establishes and reinforces Candela’s desired culture and values.
· Assesses and allocate resources to approved projects.
· Prepares and issues timely status updates on active projects for review by executive leadership team and other business leaders as required.
· Performs employee performance evaluations in a timely manner and ensures business values are being applied and practiced in the group.
· Other duties as assigned.
Knowledge/Educational Requirements
· Strong analytical, financial, and P&L skills
· Exceptional project management and leadership capabilities
· Lean/Six Sigma orientation and discipline
· Must have the ability to interact and execute at all levels of the company
· Strong results orientation, and ability to drive projects to a successful completion
· Value chain knowledge and customer centric mindset
· A minimum of a BS/BA degree in a relevant field, MBA/MS preferred
· 5+ years of experience in medical device industry
· 10+ years’ experience working in the manufacturing operations.
· 5+ years of engineering project management history and in supervising/leading others.
· Strong management skills with the ability to lead cohesive and productive teams.
· Superb working knowledge of FDA, cGMPs, and ISO registration requirements.
· Excellent oral and written communication skills
· Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents
· Ability to effectively present information to top management, public goods, and/or boards of directors
· Ability to define problems, collect data, establish facts, and draw valid conclusions
· Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
· Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
· Strong communication & organizational skills with multiple site coordination.
· Exceptional leadership skills, with ability to lead and mentor multiple levels or groups of resources.
· Innovative, persistent, and analytical problem solver to perform under often a time-sensitive environment
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.