Manufacturing Transfer Project Engineer

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Manufacturing Transfer Project Engineer for a 18 month + Contract .

Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

This position will be responsible for the successful integration of a Campus operations into our clients systems and standards.

This role will do QMS GAP assessments, remediation plans and execution, document current processes into current client procedures, creation of risk documentation / pFMEA, equipment and process validation protocols and execution.

Create and deploy preventative maintenance procedures and cadence. Support the physical relocation of machinery between sites.

Assess single points of failure and the need for backup parts. Then following the integration activities, this role will be responsible for supporting a successful product transfer to a new site with equipment moves and validations as well as Site closure protocols.

Responsibilities :

• The Project Engineer works within a cross functional team to execute various tasks within the manufacturing transfer process per associated timelines, quality requirements and budget.
• Works with current suppliers to understand how components and sub-assemblies are manufactured, review validation documents, conduct Supplier Quality evaluations in order to plan the transfer of manufacturing process to our clients manufacturing sites or other new suppliers / contract manufacturers.
• Reports observations / problems clearly and concisely, recognizing and highlighting specific deviations.
• Provide feedback and redlines on manufacturing work instructions, layouts, and equipment.
• Provides on-going status reports including periodic reviews progress and evaluation of results to management.
• Work closely with other functional areas of the company to drive successful project implementation.
• Actively engages with Manufacturing Operations to evaluate existing process layouts in terms of new process integration, ensuring best utilization of floor space, minimized handling and optimum process flow.
• Travel to meet with suppliers within United States travel 20-40%

Preferred Qualifications :

• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
• Strong communication skills with the ability to effectively work cross-functionally and externally as required.
• Knowledge of manufacturing processes, materials, product and process design.
• Must be able to read and interpret complex engineering drawings
• Supplier Quality Engineering / auditing experience preferred
• Familiarity with PPAP, control plans and validation is preferred
• Experience in an FDA regulated environment (preferably Medical Device) or regulated industry beneficial.
• Experience with managing Manufacturing transfer projects very beneficial
• Experience in ECR / ECN and systems such as onePLM, Windchill & SAP beneficial
• High level of PC Skills required. (MS Excel, Access, PowerPoint, MS Project).
• Preferred Experiences :
• B.S in Mechanical / Industrial / Electrical Engineering or related engineering discipline with minimum 5 years' work experience.
1 day ago