Sustaining Engineer

The Sustaining Engineer is responsible the ongoing sustaining support of the company products and processes sites and new product development transfer to manufacturing. The Sustaining Engineer will work as a team member with the Manufacturing, Quality, Procurement, and R&D organizations to ensure the successful ongoing production of legacy Medical Devices and the transfer of new products into the Manufacturing sites.
• Successful track record managing complex high-tech projects.
• Works independently; self-directed.
• Manage localization activities with Manufacturing sites and Sustaining Engineering.
• Ensure new processes have adequately demonstrated specified process and test control capabilities.
• Specify and procure capital in the support of manufacturing and test processes.
• Strong written communication skills.
• Medical device R&D experience highly preferred.
• Works closely, and coordinates efforts with PDP project managers, Research & Development (R&D) Managers and R&D Directors
JOB QUALIFICATIONS:
• Proficiency in MS Office Software (including Excel, Word, PowerPoint, & Access)
• Ability to manage multiple initiatives simultaneously
• Demonstrated leadership and management skills
• High level of attention to detail
• Excellent communication and interpersonal skills, negotiating, goal setting; planning and organizing teamwork; ability to address difficult situations; able to understand technical information
• Works independently/ Self-directed
EDUCATION:
• Required: B.S. Engineering (ME/EE/BME Preferred);
• Preferred: MS / MBA a plus.
EXPERIENCE (please note required or Preferred):
• 3-5 years of experience working in engineering practice. Medical device manufacturing is an advantage
• Demonstrated strong planning and organizational skills
• Experience working with FDA Quality Systems Regulations and ISO Quality Systems.
• Familiarity with SPC, Experimental Design, Statistical Sampling Techniques, Process validation, and Lean manufacturing/Six Sigma concepts and understanding.