Senior Director of Engineering

Summary of Objective:

The main responsibilities of the Senior Director – NPI Engineering is focused on the planning and execution of projects from estimating to launch:

• Manage and communicate the site portfolio of NPI projects, ensuring projects are managed to intended capital and resource cost and scope
• Provide resources and oversight to project estimating activities to develop a trusted project resource plan
• Own the resource planning process for the NPI engineering team, coordinated with other functional leaders (quality, validation, facilities, etc.) providing resources to project teams.
• Provide support to project teams, taking on risk mitigations, issue resolution, and escalations to ensure on-time launches at target quality and unit cost
• Leading change and continuous improvement activities for the NPI process
• Primary Key Performance Indicators (KPI) are On Time Equipment Commissioning and Product Launch; Project Cost Performance; Product Launch Quality and Cost Target Achievement

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Oversees NPI engineering project management.
• Supervises a staff of engineers and/or engineering technicians and provides guidance, leadership, and mentorship in areas of engineering, project management, and professional development.
• Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan.
• Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements.
• Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by site Project Managers.
• Adapts NPI engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring.
• Communicates significant equipment or process issues to site leadership.
• Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues.
• Ensure effective communication, planning and coordination between other functions
• Prepares equipment/engineering estimates for potential projects (to be submitted to sales).
• Analyzes sales requests to determine equipment, tooling, or delivery systems needed.
• Oversee the Engineering review of all components for new jobs (size, capability of equipment, bar codes).
• Conducts and/or participates in customer meetings and attends occasional off-site meetings.
• Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
• Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology.
• Coordination of outside design, integration, and equipment manufacturing services.
• Manages the site facilities and utilities to accommodate new equipment and meet all regulatory requirements.
• This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in Engineering or related field
• 7-10 years experience in a related industry
• College Level Mathematical Skills
• Program and Project management
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• High standard of report writing.

Preferred:

• Ability to adapt to changing work environments.
• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or as part of a team.
• Ability to display excellent time management skills.
• Lean/Six Sigma training
• GAMP5 experience with drug-device assembly processes