STAFF ENGINEER Job in San Angelo, Texas Us
Ethicon, Inc., a Johnson Johnson company, is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
Ethicon, a member of the Johnson Johnson Family of Companies, is recruiting for a Staff Process Engineer in Operations organization located in Irving, Texas.
Responsibilities
The Staff Process Engineer serves as the operations technical team lead and working member for new product development programs. They provide the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: RD, Quality Engineering, Clinical Teams, Analytical Labs, Procurement, Manufacturing, and Environmental/Safety. 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 lead and coordinate the design and development of components and systems in support of medical device manufacturing processes especially Silicon or polymer based. 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 JJ 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 less senior engineers and technicians, estimates manpower needs and schedules and assigns work to meet completion date.
Qualifications
BS in Engineering or relevant discipline, advanced degree preferred. MBA is a plus.
10 + years experience working in industry is required. Process engineering experience is also required for this role. It is essential to have regulated industry knowledge and medical device industry experience is a plus.
Demonstrated 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 components and systems in support of manufacturing production processes preferred.
Thorough working knowledge of the validation requirements is required.
Demonstrated 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
Working knowledge of 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. is an asset for this role.
Proficiency with Microsoft Office, CAD, and a working knowledge of statistical software such as but not limited to Mini Tab is required.
Demonstrated experience in the development and execution of project plans is preferred. Vendor or Supplier interaction is also preferred in this role.
Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and senior management.
Strong time, budget, and program management skills are preferred in this position.
Experience in leading technical teams and influencing others is an asset.
Mentors less senior engineers is also an asset
Able to travel up to 20% both domestic and international is required.
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