Senior Engineer - New Product Introductions-7108140428
Description
Ethicon LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Senior Engineer – New Product Introduction for the facility located in San Lorenzo, PR.
The Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility hosts over 1,000 associates dedicated to producing world-class medical devices to safely and effectively meet the needs of patients from all continents. Ethicon LLC, develops and markets products within three divisions: Ethicon Products for precise wound closure and tissue repair, Ethicon Women’s Health & Urology for minimally invasive women’s health procedures, and Johnson & Johnson Wound Management for homeostasis and advanced wound care.
The Senior Engineer – New Product Introduction manages most aspects of a project or initiative. This role is responsible for problem identification, root cause analysis, project management, financial analysis, project development, efficiency or productivity improvement, and problem resolution. Interfaces directly with other San Lorenzo and Corporate functional groups to ensure that goals/objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Coordinate design and process changes as well as continuous and productivity improvement activities. Manages and executes projects and/or programs of moderate to high level complexity insuring safety, regulatory compliance, company standards, operation requirements and business needs. Provides project management guidance and business tools, utilizing a systematic approach to project execution. Prepare management reports and presentations. Effective project planning and structure. Sets the engineering standard and direction for the group and is recognized as the source for guidance in a field. Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner. Defines, analyzes, reviews and evaluates problems for prompt solutions. Challenges the “status quo” on a routine basis and Develops new ideas within incoming technologies, processes and innovated products. Coordinates phases of work with other departments within the company (San Lorenzo) and with other Ethicon divisions. Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations. Revise and maintain engineering, equipments and process procedure. Participates in GMP audits regarding equipment recording and machine performance. Coordinates communications and interfaces within end users (Ethicon San Lorenzo) and machine manufacturers or suppliers. Participates in projects involving other departments and activities. Writes, develops and implements validation procedures. Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department. Takes a leading position in coordinating efforts from the beginning of the product/process development through the transfer to manufacturing environment. Takes ownership in executing product development strategies, utilizing standardized tools and methodologies, and prioritizing of business objectives. Hands-on product development and process engineering in Manufacturing Plant. Authors development protocols, technical reports, and sections of product development reports. Utilizes strong design of experiments and statistical analysis techniques. Capable of incorporating Design for Manufacturing concepts into product development strategy. Presents oral and written reports to communicate progress. Works closely with R&D Product Platform project managers, Engineering Subject Matter Experts and Material Leads to effectively implement strategies. Provide support to Management in coaching and developing technical skills of engineers and technicians. Adheres to environmental/safety policy and procedures and supports department safety objectives. Additional responsibilities of the role include: Executes and analyzes product development activities on R&D pilot lines and prototyping laboratories for new products; Provides technical support to regulatory submissions; Develops engineers and technicians by providing coaching in area of expertise; Writes technical reports to capture knowledge generated; and performs other related duties as assigned by management.
Qualifications
A minimum of a Bachelor’s degree in Engineering is required; Electrical, Mechanical or Chemical majors preferred. A minimum of four (4) years of experience in equipment/process validations, including new product introduction is required, preferably in a Medical devices industry. Process Excellence (Green Belt or Black Belt) and Lean certifications are highly preferred. Advance computer skills and use of software application(s). Strong computer background (MS Office, PowerPoint, Word, Excel, Outlook, etc.) is required, MS Project Management is preferred. Experience in a manufacturing environment developing manufacturing standards and new product and new technologies. Proficient in project management, creating credibility within team members and expanding capabilities of the group. Experience or knowledge in short and long term project management is required. Fully Bilingual (English and Spanish, oral and written) is required. Strong organizational, interpersonal, oral and written communication skills. Ability to prioritize multiple commitments and technical problem solving ability. Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches. Ability to read, analyzes, and interprets general business periodicals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals and to effectively present information and respond to questions from groups of managers, customers and other employees of the organization. Physical requirements of the position include light to moderate walking, visual inspection, bending and stretching. Requires working / visiting all shifts and flexibility to work holidays or irregular hours including weekends, per the operational needs. Availability to travel inside and outside Puerto Rico (mainly to US) twenty five percent (25%) is required.
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J2W:LI
Primary Location:North America-United States-Puerto Rico-San Lorenzo
Organization: Ethicon Puerto Rico LLC (7596)
Relocation: Eligible No
Travel:Yes, 25 % of the Time
Job Function: Process Engineering
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