Cyberonics, Inc. pioneered the Vagus Nerve Stimulation (VNS Therapy) System. Founded in 1987 to design, develop and market implantable medical devices for the treatment of epilepsy, Cyberonics has emerged as a leader in the neuromodulation industry. Cyberonics is committed to advancing the treatment of epilepsy through new technologies.
We are currently seeking a Senior Manufacturing Engineer to join the team at our Houston, TX facility.
RESPONSIBILITY AND AUTHORITY
This position is responsible for optimizing the manufacturability of products. Responsibilities include design, develop, and validate manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
• Works with developmental project teams to drive the transfer of new products and capable processes to production.
• Identifies, sources, and develops opportunities for implementing automated equipment systems (automation) and upgrading existing processes with innovative technology solutions.
• Leads technical and project management activities associated with manufacturing process improvements, validations and new technology transfer to manufacturing.
• Leads efforts to develop new processes for existing and future product lines.
• Design and qualifies new and complex equipment, fixturing, or tooling and implements these into existing or future manufacturing processes.
• Uses statistical tools to perform data analysis.
• Perform IQ, OQ, and PQ validation activities.
• Develop and provide Design for Manufacturability data for new products, based on actual experience of previous products. Develop effective action plans to avoid and resolve manufacturing issues.
• Create and maintain tooling drawings and shop orders in coordination with the Quality Assurance and R&D functions.
• Coordinate work of assigned technicians and temporary workers as needed.
• Plan and schedule projects in a manner consistent with corporate objectives.
• Maintain accurate documentation of concepts, designs, and processes.
• Participate in facilities engineering and planning when appropriate.
• Ensure GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions. Accurate and timely completion of manufacturing documentation including manufacturing procedures, material records, etc.
• Provide technical leadership, training, mentorship to engineers and technicians.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Performs other duties as may be required by supervisor.
MINIMUM REQUIREMENTS AND QUALIFICATIONS
• B.S. in Engineering
• 7+ years manufacturing experience in medical device, or pharmaceutical, or other heavily regulated industry such as aerospace.
• Exposure to manufacturing technology
• Knowledge of standard machine shop equipment
• Excellent communication skills both oral and written; ability to communicate technical concepts graphically and written
• Experience with quality system documents, IQ, OQ, Non-conformances and Corrective Actions
• Experience with Robotics, Automation, Tooling, and Fixtures
• Proficient with mechanical design/3D modeling using CAD software such as AutoCAD or Solidworks.
• Proficient in MS Office software
• Familiar with statistical analysis methods
• Hands-on problem solver
• Must able to work effectively in or lead a cross-functional team environment
• Desire to mentor others
DESIRED SKILLS AND QUALIFICATIONS
• Experience with the medical device industry, manufacturing Class II/III medical devices, specifically with cardiac pacemaker leads or catheters
• B.S. Mechanical Engineering with 8 or more years experience
• Knowledge of FDA requirements as they relate to manufacturing
• Experience with establishing and supporting manufacturing processes such as manual assembly, medical device packaging and labeling, resistance spot or laser welding, or injection molding or extrusion.
• Experience with designing and implementing automation or robotic equipment
• Experience with DFMA concepts
• Experience with transferring new products from development to production
• Experience with developing new processes from concept to realization
• Project Management training and experience.
• Lean/Six Sigma Black Belt Certified
• Experience with implementation of Lean Sigma concepts
• This position may require business travel.
Why work for us?
At Cyberonics, your talent can touch the lives of people everywhere. Whether you choose an opportunity in engineering, manufacturing, marketing, sales, finance or case management, you will contribute to the next generation of neuromodulation therapy.
Cyberonics is committed to creating an environment that addresses the real-world concerns of its workforce. That commitment includes a network of benefits and support systems that help employees manage personal issues such as health care, retirement planning, life insurance protection and continuing education.
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