Product Management Staff Engineer

Mentor Corporation of Johnson & Johnson is recruiting for a Product Management Staff Engineer, located in Irving, TX!

Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.

Under the direction of the applicable PM Manager, manages most aspects of multiple projects or initiatives. Role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Lead multifunctional, cross-departmental projects and initiatives geared towards achieving process improvements, cost reductions, new process/product introductions, and quality improvement

Key Responsibilities

• Under the direction of the applicable PM Manager and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Plans, documents, and executes new process development, designed experiments, validations, qualifications (IQ, OQ and PQ), testing, and design control deliverables in order to launch high-quality, compliant new products into manufacturing while meeting time, cost and margin targets.
• Monitors and supports new product processes until stabilized, and fully transferred into production.
• Leads and implements projects and/or programs of moderate to high-level complexity ensuring safety, regulatory compliance, company standards, operation requirements, and business needs are met.
• Provides project management guidance and business tools, applying a systematic approach to project execution.
• Prepares management reports and presentations.
• Effective project planning and structure.
• Develops imaginative strategies for the efficient completion of projects.
• Sets the engineering standard and direction for the group and is recognized as the source of guidance in a field.
• Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, and standard cost, and capital investment management in an innovative manner.
• Challenges the “status quo” on a routine basis and develops new ideas within incoming processes.
• Coordinates phases of work with other departments within the company and with other Ethicon divisions.
• Technical support to Manufacturing Business Units for complex process issues, where a higher level of technical expertise in a given field of knowledge is required.
• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies, and Federal, State, and Local Government Regulations.
• Revise and maintain engineering, equipment, and process procedures.
• Participates in GMP audits regarding equipment recording and machine performance.
• Coordinates communications and collaborates 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.
• Follow J&J Safety Requirements and ensure safe working conditions and practices in the department.
• Reviews and analyzes data, understand statistics and the application of statistical data, able to resolve normal and non-normal data along with probable causes of non-normal results.
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Responsible for communicating business-related issues or opportunities to the next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
• Performs other duties assigned as needed.