Senior Manufacturing Engineer, Operations Systems

Responsibilities

• The Sr.

Manufacturing Engineer, Operations Systems provides leadership in the engineering, design and development of new products or changes to existing products, processes, and equipment.

• Interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing development of neurovascular devices.
• Provide engineering support on existing devices for manufacturing.
• Create and execute an integrated cross-functional project plan.
• Fluently navigate quality management systems within scope and have general knowledge of quality systems beyond scope.
• Develop new processes for medical devices and components.
• Execute tasks independently and does not require assistance nor guidance.
• Think strategically within scope.
• Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally.
• Lead cross-functional team to plan and implement changes and improvements to operational systems and processes.
• Lead identification, discussion, and mitigation of project risks to successful completion of tasks and activities.
• Document manufacturing and production development process through lab notebooks, engineering protocols, and engineering reports.
• Perform research and integrate new technologies into existing and future products and processes.
• Solve practical problems encountered.
• Create and modify product design specifications.
• If in a supervisory position, select, manage, train, and develop staff.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree and 4+ years relevant engineering experience, or an equivalent combination of education and experience
• Master’s degree preferred
• Detailed knowledge of GMP/Quality System Regulations and clean room environment practices
• Demonstrated knowledge of engineering and scientific principles
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Excellent written, verbal and interpersonal communication skills required
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired
• Proficiency in Word, Excel, Power Point, Access, and other computer applications required
• High degree of accuracy and attention to detail
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.
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