Senior Development Process Engineer

Primary Responsibilities

• Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency
• Coach, mentor, and provide guidance to technicians, trainers, and operators
• Manage projects which include new production equipment, process development/improvements and cost reductions while supporting new product introductions
• Conduct equipment qualifications and process validations
• Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC)
• Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment
• Work cross functionally with R&D, Finance, Quality and Operations to define process inputs and outputs
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s Degree in Chemical, Industrial, or Mechanical Engineering, or other related discipline
• 5+ years manufacturing engineering experience in medical device or related industry, including working on and documenting process improvement initiatives
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Previous experience working in a highly matrixed and geographically diverse business environment
• Strong analytical, problem solving, and project management skills
• Strong organizational and follow-up skills, as well as attention to detail
• Individual should be innovative, resourceful, and work with minimal direction
• Individual should have excellent organization, problem solving, communication, and team leadership skills
• Proficient with MS Office (Word, Excel, Outlook, PowerPoint)

Preferred Qualifications

• Medical device experience
• Previous close interface with R&D preferred
• Previous delivery system experience in design and driving yield improvements, reducing cost, while increasing capacity
• Leverage Lean 6 Sigma Green or Black Belt certification