Process Engineer II_

Columbia

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.

**SUMMARY DESCRIPTION**

The Process Engineer (level II) will coordinate with Production, Quality, Research & Development, and external suppliers to manage capital projects, manufacturing support, and continuous improvements under guidance of engineering leadership and senior engineers within the constraints of domestic and foreign Medical Device Regulations. The employee will investigate, determine root cause, and implement corrective and preventive actions for manufacturing quality issues. The engineer will initiate and lead the implementation activities for changes approved within the change management program. The Process Engineer will also manage and drive capital projects including design, build, commissioning, and qualification, ensuring the proper goals and milestones are met on time and within budget. The process engineer will work within cross-functional core teams on the development of new products ensuring on-time transfer of new products to production.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**

+ Investigate process & equipment failures, work with production to determine root cause ,and implement corrective and preventative actions.

+ Evaluate, implement, and monitor processes and equipment for the manufacture of medical products.

+ Lead continuous improvement programs by implementing measures to improve production methods, equipment performance, and quality of product.

+ Function as the manufacturing lead for process validation and process monitoring.

+ Author & review IQ, OQ, and PQ protocols in addition to performing process validations.

+ Provide key technical and project management support in capital projects.

+ Utilize Process Failure Mode and Effects Analysis (PFMEA) and Design of Experiments to analyze manufacturing processes.

**Additional Responsibilities**

+ Interface with procurement to identify and evaluate new and replacement raw materials.

+ Ensure proper documentation is completed to meet quality system requirements.

+ Assist with the preparation and completion of cost estimates, reports, forecasts, schedules, and budgets.

+ Interface with others in the organization to ensure deadlines, quality requirements, and production metrics are met.

+ Mentor junior engineers on cGMPs and good engineering practices, as applicable.

**Travel Requirement**

+ 5% – 10% travel required

**DESIRED MINIMUM QUALIFICATIONS**

**Education & Experience:**

+ Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline.

+ Minimum of 5 years of industry experience in engineering; medical device industry experience is a plus.

+ Lean Six Sigma Experience is a plus.

+ Cleanroom manufacturing experience is a plus.

+ Computer proficiency.

**Required Knowledge, Skills, and Abilities**

+ Demonstrates strong work ethic and job performance in both independent and collaborative settings.

+ Demonstrates competence in performing/leading root cause investigations.

+ Demonstrates competence in initiating & leading manufacturing changes through change control.

+ Demonstrates understanding of design control.

+ Demonstrates ability to author technical and controlled documents for engineering, such as study reports and SOPs.

+ Demonstrates competence in specific applicable engineering disciplines.

+ Demonstrates ability to work & deliver results independently.

+ Demonstrates leadership in groups and teams.

+ Demonstrates ability to plan & schedule work in order to deliver on small - medium project timelines (up to ~1 year).

+ Communicates effectively with management and peers.

+ Proficiency in statistical analysis such as tolerance interval analysis, capability analysis, hypothesis tests and design of experiments.

+ Project Management skills including critical path identification, delegation, risk management, stakeholder management, and effective communication are required.

+ Experience leading and implementing smaller cross-functional projects.

+ Ability to manage multiple projects and tasks simultaneously.

+ Excellent analytical thinking and technical writing skills.

**TOOLS AND EQUIPMENT USED**

+ Typical office equipment (computer, phone, etc).

+ Lab equipment: Comfortable using engineering measurement devices: multi-meter, thermal mapping, data loggers, etc.

+ Software: familiarity with CAD (i.e. solidworks) and statistical analysis (i.e. minitab).

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 (eoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (eoc.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 (eoc.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 [email protected] or call us at 855-936-2666.

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