Military Spouse Connection Jobs

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.

Reporting to the Director of Process Engineering, this position is responsible for support of product development (new product introduction) and process improvement activities. Assess feasibility of and assist in the development of new manufacturing processes for new and existing products. Develop specifications for new manufacturing equipment, and prepare such equipment for validation within a medical device manufacturing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Work as part of a cross-functional team (Manufacturing, Technology Transfer, QA/QC/RA, Engineering, Facilities, Materials Management, Finance, Marketing) to transfer implantable collagen 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 Regenerative products.

• Perform hands-on laboratory work for fabricating, prototyping, testing, DOE to optimize and scale-up processes from R&D to full-scale manufacturing. Development of specifications for new processes.

• Work with Laboratory Operations to maintain laboratory equipment, materials, and any necessary procurement of materials required for laboratory activities.

• 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.

• 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 and Technology Transfer Engineering personnel on new manufacturing processes and changes implemented to current manufacturing operations.

• Take part in technical teams for identified projects and products, which may include personnel from Engineering, Technology Transfer, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs.

• Generate technical documents/reports (engineering studies, validation, URS, FAT) and compliance documents (ECO, batch records).

• Ensure that all appropriate documentation and 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 Technology Transfer Engineering, Manufacturing, Sustaining Engineering, Regulatory, and Quality Assurance.

• 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, Pharmaceutical Engineering, Chemical Engineering, Materials Science, or equivalent.

• Use of statistical process tools highly desired: Minitab, Six Sigma, Lean are a plus

Experience

• 3+ years of experience in medical device or pharmaceutical 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, lyophilization or biomaterials are desirable.

• General chemistry, processing and materials expertise.

• Exceptional problem solving skills.

• Practical product fabrication, machining and/or electrical engineering knowledge a plus.

• Use of statistical process tools highly desirable, Minitab a plus.

TOOLS AND EQUIPMENT USED

• Be fully versed in the use or Microsoft Office software and tools (Outlook, Project, Powerpoint, Word, & Excel) and use of statistical tools.

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/ada_veterans_employers.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)