Engineering Manager

The Engineering Manager has overall responsibility to lead the site Engineering team to ensure achievement of, and continuous improvements to, site metrics of Safety, Quality, Delivery, Inventory, Cost and People. This role ensures legacy products and processes are sustained and improved to the above-mentioned metrics. Additionally, this role oversees the successful transfer of new and existing products with the required processes in a timely manner and alignment with all regulatory, quality and site requirements.

Essential Functions: 

• Coordinate the initiation, funding approval and implementation of all Engineering-related new and improved processes and equipment in support of new product introduction, legacy products, Operational Excellence initiatives, capacity, growth and future business.


• Work with the Operational Excellence (OPEX) and Tech Transfer teams to develop and implement a holistic Total Predictive Maintenance Program (TPM) that spans across all divisional work centers within the Supply Chain.


• Lead Site efforts aligned with Global Procurement which impact product or processes such as but not limited to; Packaging, Electronic Components, Services, and other Raw Material requirements.


• Lead Site efforts aligned with Global Engineering which impact production or other areas related to the Site.


• Coordinate changes for new product development, packaging development, product dispensing concepts, validation and implementation.


• Develop and maintain production documentation required for cGMP.


• Coordinate the procurement (with site and corporate procurement resources), acceptance, installation and validation and maintenance of production equipment.


• Take a lead role in validation strategy and execution for site rationalizations.


• Author and execute statistically relevant validation plans.


• Support production as needed to meet monthly build plan.


• Responsible for all Engineering Department management activities, including but not limited to, staffing, performance management, recognition, monitoring project management and prioritization of resources, etc.


• Manage product sustainment efforts aligned with the Product Life Cycle of each product assembled on Site.


• Provide leadership and support to team members relative to progress of work, resolution of problems and assurance that standards for quality and quantity of work are met.


• All other duties as assigned.

Education: 

• Bachelor’s Degree in Engineering, Business Administration or related field required. 


• Master’s Degree in Engineering a plus.

Certifications/Licensing:

• Six Signa or Lean Manufacturing Certification preferred.

Years and Type of Experience:

• 5 to 7 years leadership experience in engineering or manufacturing operations in a high volume, high mix manufacturing and supply chain site preferred.


• Experience in a regulated industry (FDA, ISO, medical device, etc.) a plus.

Key Required Skills, Knowledge and Capabilities:

• Practical management experience in lean manufacturing, engineering, distribution/warehouse management, quality/regulatory assurance, and supply chain management.  Previous experience leading technical teams a plus.


• Manufacturing financial experience with developing and executing to a budget including forecasting and accountability for profit/loss as well as CapEx justification.


• Previous experience in creating a positive collaborative atmosphere between engineering and maintenance teams preferred. 


• Strong computer skills with knowledge of Microsoft Office Suite (Word, Excel, Access and PowerPoint), e-mail and Internet.


• Employs a methodical approach to engineering tasks and issues, data-based decision making is a must.


• Excellent communication skills – written and verbal.


• Strong excellent interpersonal skills.


• Ability to build and lead effective teams to achieve overall organizational objectives.


• Good organization and analytical skills.


• Good presentation and selling skills.


• Knowledge of financial principles as they apply to manufacturing.