Manufacturing Engineer - NJ

Sr. Manufacturing Engineer - NJ

In this role, you will be supporting a large Medical Device/Diagnostic company and working on a project focused on a design transfer of a manufacturing line and duplicating a multi part complex manufacturing process in a new location. They will be responsible for setting up and building brand new cutting edge equipment and becoming the SME for the pieces of equipment on the manufacturing line.

Day to day:

• Define precise specifications for new equipment and packaging components, aligning manufacturing capabilities with marketing objectives.
• Apply your expertise in engineering principles and financial acumen to enhance diagnostic manufacturing performance, champion cost reductions, and achieve the highest levels of quality and efficiency.
• Ensuring that automated equipment /systems installed in production areas function according to specifications and are fully prepared for qualification activities and hand-off to production.
• Reducing equipment downtime, decreasing mean time to repair & improving throughput yield
• Plans and manages project activities for projects within filling and packaging manufacturing streams. Defines specifications for new equipment and packaging components in accordance with manufacturing capabilities and marketing objectives. Apply engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions and achieve optimum level of quality and efficiency.
• Establish New Equipment and Processes - Uses technical and business knowledge and expertise to support Operations in the design, maintenance, installation, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Aids in the preparation of user requirements, bid package, capital justification, and acceptance testing strategy for all new filling, packaging and manufacturing equipment.
• Manufacturing Documentation - Creation of a variety of documentation used to support product launches and manufacturing, including but not limited to filling records, packaging records, manufacturing records, packaging development purchasing specifications and SOP's. Initiate and oversee change requests and design change requests as needed.

Required Experience:

• Bachelor's Degree in Engineering related to Mechanical or Chemical Engineering
• Experience working hands in a cGMP environment 6+ years
• Working hands on with automated filling and packaging equipment
• Experience with surface treatment (i.e. plasma, CO2 cleaning), adhesive bonding, drying methods and micro dispensing preferred.
• Experience with injection molding of primary packaging components preferred
• Experience managing projects in a matrixed organization.
• Experience with design transfer activities for medical devices preferred.
• Experience implementing automation equipment preferred.
• Material Science knowledge is a plus.
• A self-starter who has the ability and self-awareness to understand the company's goals and project scope, enabling them to perform at a high level under minimal supervision and add value to the organization.