Changing lives. Building Careers.Joining us is a chance for you 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, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.SUPERVISION RECEIVEDReports to the Director of Process Engineering with moderate supervision and guidance from senior engineers.SUPERVISION EXERCISEDThis position does not include direct reports.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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 with vendors/suppliers to establish raw material specifications for new and/or improved processes.
Apply experience with manufacturing process equipment to support the selection and/or design and development of equipment from prototype and full-scale manufacturing.
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).
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 utilize problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
Support manufacturing process development as part of a cross-functional core team to transfer implantable collagen and acellular tissue-based products/processes from R&D to full-scale manufacturing, following Design Control Procedures.
DESIRED MINIMUM QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and/or ability required.Education
BS/MS in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Bioengineering, Materials Science, or equivalent.
Experience
0-3 years of experience in medical device or pharmaceutical environment.
Experience with Quality System Regulation (QSR), GMP, Change Control, Design Control, and Process Validation guidelines applied to the Medical Device industry preferred.
Knowledge of validation fundamentals (IQ/OQ/PQ), statistics and process capability (CpK, sampling methodologies, etc) preferred.
Experience leading and implementing cross-functional projects.
Experience in clean rooms, lyophilization or biomaterials are desirable.
General chemistry, processing, and materials expertise.
Exceptional problem-solving skills.
Practical product fabrication a plus.
Use of statistical process tools highly desirable, Minitab a plus. Lean six sigma 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.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 (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/adaveteransemployers.cfm)Integra 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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
