Associate Director, Engineering

Job Description

Essential Functions include, but are not limited to:

The Associate Director is an important Business and Operations Leader within the Integrated Process Team (IPT) at the Wilson, NC Packaging & Device Assembly Site, providing strategic and operational guidance to a team of professionals.  Responsibilities for this position will include coordinating engineering activities in support of our operations and organizational objectives, providing vision and direction, along with application of structured problem solving tools for investigation, event resolution, and continuous improvement. In addition, the position will be accountable for various compliance related activities, including assumption of key roles within the quality management systems to strengthen compliance and inspection readiness in areas including manufacturing and packaging production controls, medical device design control and transfer, quality risk management, change control, and deviation & complaint management.

This individual will influence important business decisions that ensure successful operations and business outcomes, in accordance with established procedures, adhering to all domestic and international quality, safety, and environmental guidelines. They will manage a portfolio of projects or initiatives that are prioritized and resourced to deliver key business goals for the IPT and the site. They will provide technical and process direction and support to a technical team and to our production operations team in a wide range of capacities ranging from analysis of operating performance, management of key operational data within SAP, application of advanced problem solving, and data-driven decision-making. They will strategically and tactfully integrate programs, processes, and ideas that support employee engagement and development across all levels of the organization. 

Primary Activities include, but are not limited to:

• Utilize a high degree of independent judgment and decision-making to direct production, engineering or support operations personnel to ensure customer supply requirements are achieved in a manner that is sustainable and cost-efficient.

• Drive compliance activities to include quality chapter ownership, defect elimination, procedure writing and development, coordinate deviation response activities.

• Assume direct oversight of engineering resources to drive continuous improvement, event investigation/management, and project management activities.
• Build and enhance standards for analyzing line performance and metrics; collaborate with production planners, coaches, engineering, and maintenance teams to drive efficient utilization of manufacturing assets.
• Review volumes, determining opportunities and risks and defining performance targets.

• Act as central point of contact for the IPT; lead and support continuous improvement projects (Lean, Constraint management, Continuous Improvement).

• Monitor IPT project portfolio in conjunction with cross-funcitonal teams to ensure effective prioritization, project management, and issue escalation.

• Facilitate development and review of staffing levels versus Operating Plan to identify gaps and corrective measures.

• People manager - manage employee performance and facilitate employee engagement. Effectively coach and develop employees.

• Work closely with site leaders and people managers to discover and analyze performance gaps.

Education Minimum Requirement:
• Bachelor of Science in Engineering field

Required Experience and Skills:
• Bachelor degree or higher required in engineering field.
• Six years of relevant industry work experience, with some experience managing multi layered organization
• Experience in Continuous Improvement, Lean Manufacturing and Right First Time Methodologies
• Demonstrated strong leadership and interpersonal skills with ability to coach, influence and support others through a culture of inclusion, feedback and empowerment
• Demonstrated ability to motivate people to achieve stretch goals
• Demonstrated experience using analytical, organizational and project management skills
• Strong written and verbal communication skills including experience in management of deviation investigations / technical writing
• Demonstrated ability to work independently as a team leader and team member

Preferred Experience and Skills:
• Relevant work experience encompassing a working knowledge of FDA  regulatory requirements
• cGMP experience in a pharmaceutical manufacturing, packaging, or device assembly environment
• SAP working knowledge
• Green or Black Belt Certification in Lean Six Sigma
• Knowledge and/or experience with formal problem solving techniques as it relates to a hands-o