Location: Boston,MA, USA
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.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.Lead manufacturing process development as part of a cross-functional core team (Manufacturing, Product Development, QA/QC/RA, Engineering, Facilities, Materials Management, Finance, Marketing) to transfer implantable collagen and acellular tissue-based products/processes from R&D to full-scale manufacturing, following Design Control Procedures.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 to establish a robust design space.Work independently with vendors/suppliers to establish raw material specifications for new and/or improved processes.Apply experience with manufacturing process equipment to lead the selection and/or design and development of equipment from prototype and full-scale manufacturing.Author & review, and execute Equipment IQ, OQ, and PQ, and Process Validation protocols and reports, as applicable.Provide subject matter expertise to support manufacturing objectives. Perform timely technical investigation and provide practical manufacturing solutions for complex CAPAS under appropriate regulatory guidelines for Medical Device Manufacturer.Support the business with proactive process monitoring and identification of opportunities for improvement.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 procedures and statutory requirements (FDA and ISO)Develop and maintain an effective cross-functional working relationship with Manufacturing, Sustaining Engineering, Regulatory, and Quality AssuranceProvide technical input for analysis of process changes in the above areas.Contribute to department strategy and budget planning.Mentor and provide guidance to junior team members.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.This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:EEO Is the Law ( | EOE including Disability/Protected Veterans ( LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ( . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ...@integralife.com or call us at 855-###-####.Integra - Employer Branding from Integra LifeSciences on Vimeo (