The primary purpose of this job is to lead New Product Introduction and Transfer Program Management Office for Manufacturing Sites related to Integer's strategic initiatives. This role will work closely with Plant Leadership Teams and the R&D PMO to create and establish a framework for oversight and management of NPI and Transfer programs at manufacturing sites. This role works with internal and external customers and technical resources to ensure effective execution of NPI and Transfer programs at the Manufacturing Sites. This includes responsibility for planning, monitoring, and directing NPI programs of significant scope and complexity, including program budgets, development plans, timelines, associated documentation, or related activities associated with the new product introduction and manufacture of products, including successful transfer into the production environment.
The position will have oversight for both transfer programs from R&D and programs transferred directly from customers into a site or transfers between Integer sites; also, this position may manage new technology development and multisite implementation programs. The position will implement Integer PMO best practices at the site and develop site specific best practices where needed. This role will have responsibility for directly managing site programs; and in addition, may require direct or indirect management of other Program Managers.
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.
- Development, leadership and management of the NPI & Transfer Program Management Office functions with manufacturing sites; and implements Integer PMO best practices at manufacturing sites.
- Partner closely with site engineering and operational leadership to plan, develop, and direct new product introduction activities from inception through successful product transfer into production.
- 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 NPI and Transfer Project teams, serving as a member for those or other business teams, as assigned.
- Primary point of escalation for site NPI and Transfer Programs and on respective projects. Receives and responds to requests for service or information, participates in status meetings (internal/external), 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.
- 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.
- Support Application Engineering in new program assessments and quote development, which may involve visits to customer sites to assess technical requirements, general project requirements or manufacturing readiness for Line Transfer Programs.
- Supports the ongoing implementation and maintenance of an effective product development system, which helps to ensure safe and effective product.
- Provides mentoring and training to associates within the site NPI teams, Transfer Project teams, cross-functional teams, or others, as required.
- May indirectly manage other Program Managers
- Regular and timely attendance.
- Performs other duties as required.
Education & Experience:
- Bachelor's degree in engineering or science. Master's degree in business or technical field preferred.
- Certification from an accredited institution in Project/Program Management preferred.
- Minimum of ten (10) years of medical products industry experience in addition to six (6) 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
- Must operate with and display system-based thinking at all times.
- Ability to manage at both a broad and tactical level.
- Must be able to proactively identify potential technical and business risks that could impede the successful execution of production transfers.
- Must possess a solid set of structured problem-solving skills and be able to lead core team members to resolve issues that may arise during an NPI or transfer project.
- 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.
- Knowledge of current FDA, ISO, MDD, and other pertinent Design Control requirements.
- Comprehension of product & process development engineering principles, sufficient to allow participation in new product development programs or other projects.
- Broad experience base with manufacturing of medical components, subassemblies and finished devices.
- Physical Requirements:
- Primarily works from a sitting or standing position. Sitting often for extended periods of time. Frequent walking.
- Occasional lifting (up to 20 pounds, rarely).
- Capable of domestic and international travel.