Senior Process Engineer - Plainsboro, NJ

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Reporting to the Director of Product Development this position is responsible for support of product development and manufacturing operations activities. Assess feasibility of and assist in the development and validation of new manufacturing processes for new and existing products. Develop specifications for new manufacturing equipment and implement such equipment for use within a medical device manufacturing environment. RESPONSIBILITIES: Work as part of a cross-functional team (Manufacturing, Design Quality, Regulatory, Quality Assurance, Product Development, Engineering, Facilities, Materials Management, Finance, Marketing) to transfer implantable synthetic based products/processes from R&D to full-scale manufacturing, following Design Control Procedures. Lead and manage efforts to create novel processes, leading to full scale manufacturing of Integra products at Integra sites or approved contract manufacturers. Perform hands-on laboratory work for prototyping, testing, DOE to optimize and scale-up processes from R&D to full-scale manufacturing. Development of specifications for new processes. Work independently with vendors/suppliers to develop new equipment and establish raw material specifications for new and/or improved processes. Apply experience with manufacturing process equipment to lead the selection and/or design of equipment from prototype and full scale manufacturing. Work to gain expertise in Integra's current technical proficiencies and manufacturing processes. Provide daily analytical and technical support to meet manufacturing objectives. Perform timely technical investigation and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturer. Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities. Train manufacturing personnel on new manufacturing processes and changes implemented to current manufacturing operations. Lead teams in performing and updating Process FMEA risk management. Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs. Generate technical documents/reports (engineering studies, validation, URS, FAT, production SOPs), compliance documents (ECO, DMR, batch records) and business documents (BOM, routings, standard costs, and Manufacturing Plans for new products). Ensure that all appropriate documentation, drawing specifications are generated in compliance with Integra's and/or SIA's procedures and statutory requirements (FDA and ISO) Develop and maintain an effective cross-functional working relationship with Manufacturing, Sustaining Engineering, Regulatory, and Quality Assurance Support investigations related to product nonconformances and CAPAs. Provide technical input for analysis of process changes in the above areas. DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required. Education BS/MS in Mechanical Engineering, Textile Engineering, Materials Science, or equivalent. Use of statistical process tools highly desired: Minitab, Six Sigma, Lean are a plus Experience 7+ years of experience in medical device environment. Experience with Quality System Regulation (QSR), GMP, Design Control, and Process Validation guidelines applied to the Medical Device industry. Knowledge of validation fundamentals (IQ/OQ/PQ), statistics and process capability (CpK, sampling methodologies, etc). Experience in clean rooms, textile processing, and/or biomaterials are desirable. Exceptional problem solving skills. Practical product fabrication a plus. Use of statistical process tools highly desirable, Minitab a plus. Must be local to Plainsboro, NJ 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. 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Created: 2024-10-29