Location: Buffalo,NY, USA
The Project Engineer, NPI is responsible for supporting the development of new processes and carrying out each trial exactly to the established product specification. This includes managing the program from early prototype builds through to the launch of the production line.
The primary role of the Project Engineer will be to test and validate systems and parts involved in product development and manufacturing in order to ensure products are of the highest quality. To support this, the Project Engineer will also establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records. The Project Engineer will identify, report, and adjust equipment or processes that require improvement.
The Project Engineer will collaborate with safety, design, product excellence, change control, manufacturing, and service departments.
* Assist in validating manufacturing processes to ensure product specifications and standards are achieved
* Lead manufacturing line trials for new products and processes
* Manage quality assurance and procedures by testing and validating systems and parts; Assist in establishing and implementing new validation standards, and procedures
* Conduct Trial Preparation: Ensure part availability, line readiness, and pre-requisite data obtained and consolidated
* Complete Trial Report: Document observations, analysis, and results, Make recommendations as needed and drive solutions. Record all issues found during trials and help drive to closure
* Manage Trial Recovery: Ensure manufacturing lines are validated and/or restored to prior condition post-trial(s). Evaluate the success of each trial (yield, downtime, cost, capacity, safety, etc.)
* Serve as subject matter expert (SME) on trials to ensure proper validation procedures are followed
* Collaborate with cross-functional teams to evaluate the best processes roll-out
* Track all trial details in PCA tracking system for approvals
* Lead and provide feedback in change control meetings
* Degree in Mechanical, Electrical, or Manufacturing Engineering, or equivalent working experience
* 5+ years' experience in a manufacturing environment; Experience with semi-automated manufacturing equipment is a plus
* Understanding of manufacturability, process design, process validation, and assembly methods; Have an aptitude to learn and incorporate new technologies
* Experience breaking down high-level (e.g. device level) performance issues into addressable action items; Ability to identify issues and make corrective measures to resolve
* Skillful with electrical and computer-based tools, including precision measuring equipment, electrical test equipment, and computer databases
* Understands and appropriately applies principles, procedures, requirements, and policies related to specialized projects
* Proven ability to operate under pressure with rigid time constraints; Can track and manage multiple tasks simultaneously; Ability to work in a fast-paced environment, occasionally requiring extended hours
* Can work closely with cross-functional departments; Excellent written and verbal skills; Ability to communicate across cultures and geographic regions