The primary purpose of this job is to manage R&D projects that are related to Integer's strategic initiatives. This role works with internal and external customers and technical resources to ensure an effective execution of the program. This includes responsibility for planning, monitoring, and directing R&D projects and programs of highest scope and complexity, including project budgets, development plans, timelines, associated documentation, or related activities associated with the development and manufacture of products, including successful transfer into the production environment.
Accountabilities & Responsibilities:
- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Plans, develops, and directs product development project activities from inception through successful product transfer into production. Leads, documents, and facilitates project planning and execution to completion of project tasks.
- Prepares, monitors, and ensures adherence to master project/development plans, quotes, budgets, specifications, and schedules, providing periodic status reports as required.
- Establishes milestones and provides organization, leadership, and guidance to design/development project teams, serving as a member for those or other business teams, as assigned.
- Primary contact on respective projects. Receives and responds to requests for service or information, participates in status meetings (internal/external) and design reviews, and interfaces with Integer departments, external customers, and suppliers, as necessary.
- Manages planning and communication with other functions (marketing, quality, regulatory, design assurance, manufacturing, etc.), as applicable, as it relates to project initiatives, policies, etc. Ensures projects and associated issues are effectively resolved while representing the best interests of patients, customers, and Integer.
- Provides training to Associates within Research & Development, cross-functional teams, or others, as required.
- Defines and delivers necessary project documents in accordance with Integer requirements and applicable domestic/international regulations or standards. May also evaluate, create, or modify other necessary project-related documentation, such as checklists, procedures, development information/reports, or other records required to support Integer's development processes.
- Supports the ongoing implementation and maintenance of an effective design control and product development system, which helps to ensure safe and effective product.
Education & Experience:
Minimum Education: Bachelor's degree in a technical field. Master's degree in business or technical field preferred. Certification from an accredited institution in Project/Program Management preferred.
Minimum Experience: Minimum of five (5) years of medical products industry experience in addition to four (4) years minimum in a project management capacity.
Knowledge & Skills:
- Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
- Proficient management and leadership skills and competencies • Ability to manage at both a broad and tactical level.
- Effective business consulting skills including the ability to establish rapport with key internal and external business leaders to collaborate and influence.
- Working knowledge of general business operations; able to apply concepts to establish and meet goals.
- Ability to manage key performance indicators identifying appropriate metrics and manage performance to agreed-upon service levels.
- Highly proficient verbal and written communication skills with the ability to make and deliver clear, accurate, and concise executive presentations and negotiate with customers and technical professionals.
- Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem solving skills.
- Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
- Proficient use of a PC, office software (MS Office Suite), and specialty project software (MS Project), as required.
- Specialized Knowledge:
- Knowledge of current FDA, ISO, MDD, and other pertinent Design Control requirements.
- Comprehension of development/engineering principles, sufficient to allow participation in new product development or other projects.