J&J Family of Companies Senior Manufacturing Engineer in Irving, Texas
Mentor Worldwide, a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Manufacturing Engineer, located in Irving, TX.
Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
Responsible to identify process improvement initiatives and develops proposals for problem solving, improvement or optimization. Support process improvement projects that have the objectives of developing more cost efficient and quality enhanced processes. Establish machine and process standards and overall equipment efficiency. Assist in the development of more effective operational control systems. Evaluate data generated through studies using statistical analytical methods. Responsible for the development and/or revision of production standards and standard work documents. Develops, writes and executes engineering studies, design of experiments, and IQ/OQ/PQ protocols and reports.
Works on optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction /yield improvements, budget management, standard cost and capital investment management.
Provides technical support to the production areas evaluating process deficiencies, process changes, modifications and equipment failure. Defines, analyzes, reviews and evaluates problems for prompt solutions.
Determines, adapts, and modifies methods and standards to control all aspects of assigned projects or portions of major projects.
Coordinates phases of work with other departments within the company and with other J&J divisions.
Perform investigation and writes NC reports following established timelines.
Routes and follows up on NC reports through the evaluation, review and approval processes to comply with the established timeline.
Coordinates and participates in Cross Functional Investigations (CFI )
Revise and maintain engineering and equipment procedures.
Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
Map processes and analyze current status and potential future states with improvements. Define and quantify improvements to further analyze the gains. Use tools from ME2, Lean and Six Sigma to create and execute CIP projects.
Participates in GMP audits regarding equipment recording and machine performance.
Coordinates communications and interfaces with end users, machine manufacturers and/ or suppliers.
Participates in projects involving other departments and activities (CIM, QIP, CFM, etc.).
Writes, develops and implements validation procedures.
Comply J&J Safety Requirements and ensure safe working conditions and practices in the department.
Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results.
Bachelor's degree in engineering discipline is required.
4 years' experience in engineering in a medical device or pharmaceuticals environment required.
Advanced computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.)
Proven ability to anticipate and solve problems.
Ability to prioritize multiple commitments and technical problem solving duties.
Experience or knowledge in short and long term project management.
Standard hours are 8:00am-5:00pm
This position is located in Irvine, TX and up to 25% travel, international and domestic.
Mentor Texas LP (6182)