Location: Salem, NH
• Leads cross organizational technical and engineering resources to deliver differentiating technical services to broad range of internal and external Customers
• Act as the technical expert on new medical balloon product development teams.
• Manages day to day operating’s of ESI/NPI component engineering team
• Provides leadership, coaching and development to engineering, mentors and training of subordinates to drive continuous growth within the department
• Maintain companywide Technology Road Map and champions development projects
• Initiates and recommends development projects for value-added processing.
• Delivers advanced manufacturing balloon and related component technologies
• Lead personnel in a manner that creates positive morale, encourages initiative, and facilitates the attainment of employees’ full potential.
• Interacts with customers, suppliers, and internal resources
• Coordinate and execute project deliverables working collaboratively with cross-functional team(s)
• Coaches and directs the efforts of direct reports to develop and implement plans to continually evaluate the effectiveness and efficiency of their areas of responsibility. Use the results of these assessments to improve departmental and company-wide processes.
• Participates in and contributes to the strategic and operating planning processes at the business level.
• Other duties as assigned.
• Advanced technical degree in polymer science or related field – PhD preferred but not required
• Minimum 10 years of experience in R&D or process development, with a minimum of 5 years of medical device experience or another highly regulated FDA/QSR and ISO environment
• Minimum 5 years of program/project management in medical device or other regulated FDA/QSR and ISO environment
• Prior management experience in applications engineering or R&D for a world class polymer, fluoropolymer or advanced materials company
• Demonstrated knowledge of development, manufacturing and quality systems requirements for medical devices
• Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization
• Proven experience with technology strategy and Technology Road Mapping
Preferred Skills and Abilities
• Ability to matrix manage at all levels.
• Direct experience managing applications engineering or R&D teams / programs
• High level of passion and enthusiasm to lead Customer Centric engineering and technical teams
• Experience with medical balloons and balloon catheters and catheter delivery systems preferred
• Experience with combination medical devices including regulatory approval requirements
• US FDA QSR and ISO 13485 requirements for design controls
• Strong skills in communicating with all levels of technical and operating management
• Demonstrated positive communication and human relation skills
• Strong ability to analyze and use technical data via statistical and pareto analyses and another investigational tool
Travel Required – Minimal
Contact: Please send resume to email@example.com