Staff Product Management, Process Engineering- Tissue Expanders-7461140617
Description
Mentor is currently searching for a Staff Product Management, Process Engineering- Tissue Expanders located in Irving, TX.
Mentor Worldwide L.L.C. 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. This position will primarily be focused on products used for breast reconstruction and augmentation.
The position reports to the Process Engineering Manager in the Product Management Group. The position will interface primarily with the manufacturing site in Irving, TX, but may also interact with facilities in the Netherlands and Mauritius as well as Mentor’s headquarters in Santa Barbara, CA and Ethicon’s headquarters in Somerville, NJ. To lead project teams and provide major input into the design, development, and implementation of processes for new products. Supports flawless transfer of new products and processes from R&D or other transferring partners into the Supply Chain (J&J or external) and the launch of products into regional or global commercial markets
Key Job Responsibilities:
The Staff Process Engineer serves as the operations technical team lead and working member for new product development programs. He or she will provide the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Clinical Teams, Analytical Labs, Procurement, Manufacturing, and Environmental/Safety. A Staff Process Engineer will collaborate with internal functions and suppliers to finalize product design, material and process selection. The Staff Process Engineer will prepare and review process development and validation protocols, coordinate all activities related to their execution, including the preparation and approval of completion reports, detailed process specifications and work instructions. This individual will conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities. The person is also accountable for appropriate development and execution of process development and validation activities at external suppliers.
The Staff Process Engineer uses knowledge of scientific techniques and Process Excellence to design and develop safe, effective and efficient processes in support of the company's strategies, goals, objectives and product portfolio. They observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility and comply with J&J Safety / Environmental Requirement and safe working conditions and practices. Makes decisions independently on engineering problems and methods and prepares technical reports, project updates, and status reports for team and senior management. Reviews the work of less senior engineers and technicians, estimates manpower needs and schedules and assigns work to meet completion date.
Qualifications
A minimum of a Bachelor's degree in Engineering or a related discipline is required. An advanced degree and/or MBA are a plus. A minimum of 7+ years of Process Engineering experience is required, preferably in the regulated medical device industry. Demonstrated experience in new product process design and development and implementation of these processes into manufacturing operations for current product is preferred. Experience in new product process design and development for new products / processes with multiple factors, responses and interactions is required. Experience with design and development of mechanical or chemical components and systems in support of manufacturing production processes is required. Thorough working knowledge of the validation requirements for Medical Devices with demonstrated experience is required. Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required. Must have the ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization is required. The ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities is required. Experience with Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, C/E Matrix, pFMEA, fish bone diagrams, etc., are required. A Master Black Belt is an asset for this role. Proficiency with Microsoft Office and a working knowledge of statistical software is required. Candidates who have experience using MiniTab are preferred. Demonstrated experience in project management including the development and execution of project plans is preferred. Excellent communication skills, making complex issues easy for others to understand and the ability to prepare communications for team and senior management, will be needed. Experience mentoring less senior engineers is preferred. This position will be based in Irving, TX and requires up to 15% travel, with the potential for international travel.
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Primary Location:North America-United States-Texas-Irving
Organization: Mentor Worldwide LLC (6177)
Job Function: Process Engineering
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