Our client: 

The Engineering and Research manager is responsible for the oversight and management of all engineering and research related activities at KitoTech Medical. Responsibilities will focus both on product design, implementation and testing as well as manufacturing oversight and interface with subcontractors. The Engineering and Research manager will have ownership of the development and manufacturing of the first KitoTech Medical product, will oversee the development of the product from prototype to commercial product, and ultimately first sale.

Essential Functions 
• Lead product development activities at contract design & manufacturing facilities. Interface with project teams and management at contract facilities to align activities with program requirements. 
• Develop project plans, specifying goals, strategy, resource priority, and identification of program risks. Oversee activities throughout concept, development, verification, and launch. 
• Develop validation and verification strategies for engineering projects. Assure project design and manufacturing deliverables are in compliance with Quality System Requirements, and applicable Industry and Regulatory Standards and Guidance Documents. 
• Design development and manufacturing plans with outside vendors. 
• Manage vendors currently engaged in development and manufacturing functions. 
• Provide clear communication to internal organization of product development activities, appropriate escalation of challenges to senior management, and data driven issue resolution. 
• Provide medical device development expertise to resolve engineering and technical issues. 
• Assist in identification of next generation product changes and development of product portfolio. 
• Interface with physicians, marketing, sales, and clinical teams to refine design inputs. Ensure customer inputs are incorporated and maintained throughout the product development cycle.

Education:
• Bachelor’s Degree in engineering discipline (preferably mechanical engineering), Masters degree desirable.

Experience:
• Minimum of 5+ years experience in the medical device industry, 8+ desirable. 
• Minimum 2+ product development and manufacturing projects completed (from prototype to commercial sale). 
• Experience working with disposables and adhesive based products desirable.

Skills/Qualifications:
• Quantitative modeling skills applicable to structural analysis of microstructures (e.g finite element mesh modeling). 
• Test and validation protocol and activity development for device specification verification; 
• Excellent project management skills. 
• Expertise in the Product Development cycle, including design review, risk management and testing/validation planning. 
• CAD drawing software (e.g. Solidworks, Rhino etc.) for use in drawing package development and submission to vendors. 
• Background in manufacturing of medical devices.

www.triforcetech.net

All your information will be kept confidential according to EEO guidelines.