Senior Manufacturing Engineering Specialist

Overview

The Senior Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.

The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

Responsibilities

• Independently produce, organize, and maintain documentation or systems critical to the function of the engineering team or department.
• Run short-term, long-term, and / or system-focused projects, or complete significant tasks critical to projects.
• troubleshoot manual and / or automated processes and systems
• Troubleshoot design, process, testing, and / or documentation issues.
• Installs, qualifies, and validates equipment and processes in the production area to improve yield and / or reduce cycle time.
• Support installation, calibration, qualification, and maintenance of the equipment
• Define, implement, and support preventive maintenance activities.
• Coordinate maintenance and facilities functions in asset management system
• Assist with emergency and scheduled System Breach and Recover plan.
• Develop or revise documents and procedures such as Drawings, Work Instructions, and Standard Operating Procedures
• The integration of machined components with off the shelf parts to complete the equipment. (Keeping spares to a minimum)
• The integration of electrical components. (HMI / PLC / Loadcell / sensors etc)
• The integration of any pneumatic components into the equipment. (Cylinders / regulators etc)
• The debugging of equipment PLC.
• Assisting New Product Introduction Team to introduce new equipment into manufacturing.
• Research and provide technical support of new automation / control technologies for implementation into new and existing equipment.
• Liaise and communicate with the other project team members.
• Ability to complete projects within specific timelines and meeting performance expectations.
• Drive the development and execution of experimentation and testing to enable process characterization, optimization, and troubleshooting of processes and equipment
• Build prototypes, develop manufacturing processes, perform testing, and / or develop appropriate documentation based on area of focus within the engineering department.
• Use judgment and experience to independently accomplish project objectives.
• Maintain high knowledge level related to the team's focus and relevant company systems.
• Serve as a mentor, trainer, and resource to the team within area of expertise.
• Prioritize work based on assigned goals
• Read, comprehend and follow product and packaging specifications and manufacturing instructions and drawings.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Qualifications

• AS degree in relevant field; or experience of such kind and amount as to provide a comparable background.
• 5+ years experience that relates directly to the above essential job functions / duties.
• Knowledge of medical device quality standards / practices or similar regulated industry.
• Ability to use machine shop equipment (milling machines, lathes etc) is an advantage.
• Familiarity with 3D Cad package such as Creo / Solidworks is preferred.
• Experience working independently and with minimal supervision.
• Working knowledge of Microsoft Office Software (ie : Word, Excel).
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.
• Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position.
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works under general office environmental conditions.
• Moderate exposure to noise level in the work environment that is moderate to occasionally loud.
• Occasionally lifts and / or moves up to 50 pounds
• Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; talk and communicate.
30+ days ago