Project Manager IV

POSITION DESCRIPTION

Leads multiple international teams in executing project plans, schedules, budgets and deliverables. Projects include new development and upgrade of flexible endoscopes and associated components and accessories. Identifies needed resources for projects, defines and assigns major project roles. Establishes operational objectives and work plans and delegates assignments.  Manages the development of custom medical devices primarily used for flexible endoscopic surgery from concept to pilot phases to field sustainability.

RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.):

• Provides leadership and motivation to project teams to help them reach project performance goals (quality, time, cost) in an Agile product development environment.
• Has overall product/program/project management responsibility; coordinating efforts leading to product release.
• Selects, develops, and evaluates personnel to ensure the efficient operation of various functions.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Oversees the investigation and evaluation of existing medical device technologies. 
• Effectively reports progress to stakeholders.
• Responsible for control of planning & staffing, budgeting, and managing expense priorities.
• Recommends and implements changes to methods.
• Monitors documentation maintenance throughout all phases of research and development.
• Interface with external customers or field-based employees on technical matters, as needed.

MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS:

• Bachelor’s degree in engineering or science discipline.
• 7 years minimum of experience in a Design or Manufacturing Engineering environment.
• 10 years minimum of project management experience.
• Strong communication with all levels of Global personnel, both verbally and in writing.
• Familiarity with FDA/ISO regulations preferred.
• Proficiency in Microsoft Office software (Word, Excel, Project, PowerPoint).
• Proficiency in project management soft skills and team dynamics.
• Proficiency with scheduling tools such as MS Project, analyzing business reports and managing project budgets.
• Demonstrated successful management of complex projects and influencing others to achieve desired outcome.
• Proven ability to effectively facilitate problem resolution including conflicting priorities..
• Organized self-starter - ability to work with minimal supervision.
• Must possess a high level of “people skills” regarding mentoring, coaching, and communicating to the team.
• Must be extremely organized and able to consistently meet deadlines.
• Must have excellent written and oral communication skills.
• Must work effectively with employees at all levels in the organization and keep stakeholders informed.

• Must be able to get projects done with no direct reports but with many departments, work areas, and employees within the organization being directed by and accountable to the Project Manager at various times in the project life cycle.

• Knowledge of medical device quality system regulations and standards (e.g., U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)

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