Job Summary:

Reporting to the General Manager, the Engineering Manager is responsible for leading the Engineering, Maintenance and Tool Room team to build and implement a pipeline of technical projects to meet or exceed business targets in quality, growth, and productivity.

Supervisory Responsibilities:

  • Provides supervision and daily direction to all Maintenance, Engineering, and Tooling personnel
  • Must be able to provide full direction to all direct reports.
  • Ensure accuracy and completeness of employee time cards.
  • Ensure resources are allocated appropriately.
  • Conduct Employee Performance reviews and provide continuous feedback.

Duties/Responsibilities:

Continuous Improvement

  • Drives continuous improvement efforts of products/ processes to and delivers improvements in productivity, yield and/or operating costs.
  • Accelerates delivery of engineering projects through superior project management utilizing internal and external resources to minimize time to delivery and costs.
  • Develops deep expertise in all applicable manufacturing methods and technologies. Utilizes this knowledge to improve uptime, throughput, and yield metrics.
  • Identifies areas of opportunity for efficiency improvements and cost savings, and assess viability of all engineering projects.
  • Lead capital project budgeting activities and investment initiatives including vendor/machine selection and business case/ROI, justification development and presentation

Facility Maintenance

  • Maximizes equipment availability and uptime by owning the preventative maintenance and spare part inventory programs
  • Ensures all building systems including HVAC, plumbing, electrical, and compressed air are available, adequate, and well maintained.
  • Ensures compliance with all applicable city, state, and federal environmental regulations through proper management of wastewater, air pollution, Tier II, etc programs.
  • Prioritizes maintenance technicians' workload to minimize machine downtime and ensure completion of preventive maintenance tasks
  • Creates plan and executes any plant lay-out changes

New Product Development

  • Participates in the NPD process by assessing manufacturing feasibility and performing cost/buy analysis
  • Provides CAPEX, COGS, and timeline inputs into NPD project plans. Leads new manufacturing process design including CAPEX equipment evaluation and selection, process validation plan and execution, operator training and overall NPD manufacturing project management.
  • Provides inputs on ERP system for new part numbers, bills of materials, routings, and costing standards for new products.

Standard Costing

  • Leads the annual standard costing update process including time studies, ERP standards costing updates, overhead calculations, and cost rolls.
  • Helps ensure annual costing process is completed in an accurate and timely manner.

Quality

  • Works with Quality in complaint investigation and CAPA
  • Works with Quality for equipment and process validations
  • Prepares Change Requests and CAD Drawings as needed
  • Update manufacturing routings and bill of materials as needed

Required Skills/Abilities:

  • Expertise in SolidWorks and/or AutoCAD required.
  • Solid understanding of cost accounting is required.
  • Experience in a regulated environment is required.
  • Validation experience required.
  • Knowledge of manufacturing processes, process engineering, quality system procedures, scheduling procedures, company Quality Management System along with FDA 21CFR820, MDSAP, and ISO 13485 Standard Requirements
  • Apply a risk based approached per ISO 14971 to all applicable elements of the Quality Management System
  • Strong system and data knowledge (e.g. ERP) required including medical product specifications, tolerances and examples of likely defects that may be encountered in the performance of these duties.

Education and Experience:

  • BS degree in Industrial Engineering or equivalent.
  • Minimum of 10 years of experience in a manufacturing environment in a relevant role and having direct reports.

Physical Requirements:

  • Prolonged periods standing and walking.
  • Able to bend, stretch, push, pull, crawl and move as needed to reach, clean, and service machinery.
  • Must be able to visually inspect machines.
  • Must be able to lift and carry up to 50 pounds.

Contact Karen Giannone if interested, or if you need more information.