Integra LifeSciences is hiring: Manager, Manufacturing Engineering in Plainsboro

Overview Manager, Manufacturing Engineering role at Integra LifeSciences – Plainsboro, NJ. This position reports to the Director, Manufacturing Operations & Engineering and is responsible for manufacturing engineering at the Integra Tissue Technologies Plant located in Plainsboro, NJ. This position is responsible for managing a team of engineers who provide technical support for ongoing plant manufacturing operations and leads projects to evaluate, analyze, and improve existing processes, implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, conduct non-conformance investigations, and execute CAPA projects that support manufacturing operations and the Quality System. Responsibilities Manage a manufacturing engineering team to support process scale-up for current manufacturing operations. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly. Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra’s procedures and statutory requirements. Initiate, develop and implement Engineering Studies and IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Requests/Orders (ECR/ECO) and Engineering Drawings. Oversee projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes. Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA). Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs. Project Management aimed to evaluate, analyze, and improve existing processes, support the transfer of manufacturing processes, and manufacturing process troubleshooting. Must be able to manage projects in their entirety, and also be able to perform/deliver specific project tasks as necessary. Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities. Provide plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc. Provide daily analytical and technical support to meet manufacturing objectives. Provide technical input for analysis of process and equipment changes. Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing. Evaluate and upgrade process equipment as required. Conduct performance reviews and other HR procedures and duties for departmental staff in accordance with company policy. Oversee and direct all performance management, training, development, job descriptions, and safety procedures for all direct reports. Minimum Qualifications Bachelor degree or equivalent with 5+ years of experience Experience in the medical device, pharmaceutical or similarly regulated industry with experience in process development and/or process engineering. Experience with Quality System Regulation, Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines is required. Experience with biomaterials, in cleanrooms, and Lyophilization a plus. Experience managing direct reports. Experience with Statistical Process Control tools required (SPC, Minitab, other software). General chemistry, processing and material expertise. Considerable knowledge of the principles and practices of engineering as applied to various types of projects. Ability to prepare complex technical reports, project summaries, and correspondence. Exceptional practical problem-solving skills, excellent organizational and communication skills. Six Sigma LEAN a plus. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. If you require a reasonable accommodation during the application process due to a disability, please email careers@integralife.com. Seniority level Mid-Senior level Employment type Full-time Job function Engineering and Information Technology Industries Medical Equipment Manufacturing #J-18808-Ljbffr