Cresilon, Inc.
biotechnology
DirectorofResearch&Development
“Director of Research & Development at Cresilon, Inc.. Skills: Research & Development, Medical devices, Product development. Lead, staff and manage R&D team. Launch new commercially successful products”
What You'll Achieve.
Launch new commercially successful products; Ensure new product development completed successfully; Ensure sustaining engineering projects completed successfully; Meet committed schedule; Meet product specifications; Meet budgets; Align project goals with company goals; Reflect pipeline expansion goals; Ensure research operations reflect corporate vision/strategy; Meet all budgets; Meet all schedules; Meet all performance requirements; Facilitate seamless project execution; Advance research team objectives; Advance company objectives; Ensure success and ease of communication
Industry & Context.
Diagnosing design problems; Diagnosing manufacturing problems; Conflict resolution
What They're Looking For.
Must Have
Lead, staff and manage Cresilon R&D team, Provide sound scientific leadership, Act as a technical thought leader, Play a lead role in technology transfer, Be an SME for growth strategy, Lead and direct exploratory research development, Regularly interface with Vice President of Technology, Ensure compliance with all applicable specifications, Ensure that all budgets, schedules, and performance requirements are met, Collaborate with stakeholders, functional managers, and cross-functional staff, Develop and implement investigations into new technologies, Provide technical assistance for diagnosing design and manufacturing quality problems, Guide development and documentation of test plan protocols, Review and provide functional approval for project and quality system documentation, Maintain positive and cooperative communications and collaboration, Work as part of a cross-functional team, Ensure an effective documentation system is in place, Attract, retain, and develop top-tier scientific and engineering technical staff, Develop unique, proprietary intellectual property, Lead research department review and other team meetings, Improve efficiency and optimization of existing research operation, Administrate and manage Cresilon grant, SBIR and other non-dilutive funding activities, Lead the effort to publish research in peer-reviewed journals, Develop and implement administrative tools, Develop test method capabilities
Nice to Have
Experience leading product device design and development of regulated medical devices, Working knowledge of design control of medical and/or combination product and device development, Strong knowledge of product development lifecycle, Risk management and quality systems, Working knowledge of medical regulatory requirements for Class II and III medical devices, Experience with combination products or biologic interfaces, Understanding of cGMP, ICH guidelines, Demonstrated experience in Project Management and Product Lifecycle Management practices, Experience with executing a grant and publication submission strategy, Knowledge of and track record with SBIR submissions, Prior experience implementing continuous improvement, Six sigma green belt or black belt certification
What You'll Do.
staff and manage R&D team
Launch new commercially successful products
Provide sound scientific leadership
Support and coach R&D team
Oversee discovery/innovation efforts
Provide technical expertise
Provide scientific direction
Coordinate technology transfer
Provide technical assistance
Facilitate efficient use of resources
Align personal and project goals
Lead and direct exploratory research development
Interface with Vice President of Technology
Ensure research operations reflect corporate vision
Ensure compliance with specifications
Ensure compliance with SOPs
Ensure compliance with FDA regulations
Meet all performance requirements
Collaborate with stakeholders
Collaborate with functional managers
Collaborate with cross-functional staff
Facilitate seamless project execution
Remove obstacles to execution
Develop investigations into new technologies
Develop investigations into new capabilities
Provide technical assistance for diagnosing problems
Guide development of test plan protocols
Guide development of SOPs
Guide development of specifications
Guide development of test procedures
Review project documentation
Approve project documentation
Review quality system documentation
Approve quality system documentation
Maintain positive communications
Maintain cooperative communications
Collaborate with employees
Collaborate with customers
Collaborate with contractors
Collaborate with vendors
and validate product designs
Ensure effective documentation system
Utilize R&D lab notebooks
Utilize design reviews
Attract top-tier scientific staff
Retain top-tier scientific staff
Develop top-tier scientific staff
Attract top-tier engineering staff
Retain top-tier engineering staff
Develop top-tier engineering staff
Ensure technical know-how is shared
Increase technical know-how
Develop unique intellectual property
Develop proprietary intellectual property
Develop patentable intellectual property
Lead research department review meetings
Lead other team meetings
Develop meeting agendas
Follow up on action items
Improve efficiency of research operation
Optimize existing research operation
Implement stage-gate process infrastructure
Administrate Cresilon grant funding
Manage Cresilon grant funding
Administrate SBIR funding
Administrate other non-dilutive funding
Manage other non-dilutive funding
Lead effort to publish research
Develop administrative tools
Implement administrative tools
Develop test method capabilities
How You'll Work.
Team & Collaboration
Cross-functional teams; Cross-functional staff; Cross-functional team
Communication Scope
Cooperative communications
Process & Methodology
New Product Introduction, Stage-gate processes, Product Lifecycle Management
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