Director of R&D

SUMMARY
Facilitates the direction, research, and plans for the development of new instrumentation and technologies through execution of the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Research and evaluation of new business opportunities through interaction with outside vendors, corporate partners, clinicians, universities and other engineering, biomaterial or biological firms and entities.

In conjunction with Portfolio, Project, and/or Product Management, assesses market feasibility of new product concepts in terms of market acceptance and financial benefit to the company.

Facilitates and is responsible for supervising the Return on Investment (ROI) Analysis prior to beginning any new project

Directs, educates, and supervises development engineers and technicians in the design of new products

Ensure all local (in-country) regulatory compliance for all design related activities carried out by Product Development personnel

Participate with all levels of management in the identification, direction and prioritization of the company’s product portfolio

Presentation of new product concepts and status to clinician panels, corporate partners and executive committee as required

Coordinate engineering evaluation of customer complaints and implementation of corrective action when appropriate

Plans and implements engineering programs, including defining the project scope, goals, activities, milestones, financial resources and staff requirements to meet objectives.

Develops and maintains a schedule and budget for assigned engineering projects. Provides reports on the status of project milestones and adjusts schedules accordingly.

Coordinates preparation and delivery of project deliverables, design documents, and bid packages

Supervises and manages project personnel as assigned to complete all project tasks within budgets and schedule objectives.

Coordinates and assists in development activities including design, engineering, testing, problem solving, project/design documentation, design reviews and design output generation

Coordinates and directs integration of technical and company resources to deliver projects

Prepares interim and completion project reports. Provides status and progress reports to customer, project team, and management

Supervises and Manages all Clinical Research Projects in Biomet Japan
• Write and/or review study protocols
• Develop Case Report Forms for clinical trials
• Recruit investigators for participation in clinical trials
• Assist sites on IRB approval
• Monitor (pre-study, initiation, routine, and close-out visits) study progress and data collection at sites
• Review and verify clinical data for completeness and accuracy
• Conduct data analysis and compile reports on clinical studies.
• Administer the use of Joint Assist
• Provide necessary training to sites on conducting clinical studies
• Organizing clinical research meetings with interested investigators

Work closely with Corporate Clinical Research on developing clinical studies according to clinical research strategies consistent with country and global plan.

Work closely with Corporate Clinical Research Coordination (CCRC) group on Japanese researchers’ participation in global studies.

Supervises and directs the preparation of the required documents for study proposal submission to CCRC and IRC per QM21.6

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