Process Engineer

Envista Dentistry•Yorba Linda, CA

6h•Onsite

About The Position

As a Chemical Process Engineer, she/he is responsible for planning and performing validations on new equipment, products and processes. They must complete specifying documents and perform risk analysis (PFMEA) on new products and processes or any change in those existing. While the Chemical Process Engineer will specialize in the acid and cleaning processes that occur on site, they will become the hands-on, subject matter expert on all equipmenVprocesses utilized at the Nobel Biocare Yorba Linda facility. Process Engineers must apply sound project management skills with vendors and cross functional teams to ensure that their tasks are kept on track to ensure projects are released on time. She/he will write validation reports, procedures and technical sheets when necessary and perform designed experiments to qualify and optimize production. They are responsible to create a lean manufacturing environment and also work with the sister p lant OUS to harmonize production in both locations. Accountabilities : Become the hands-on, subject matter expert on all equipment/processes/products at the Nobel Biocare Yorba Linda facility. Work with the global team on new product introductions and be accountable for local action items to assure that products and initiatives are introduced on-time, problems are minimized and communicated quickly, and products are manufactured efficiently. Serve as a point of contact for production and machine center managers to resolve product, process, or equipment issues. Specify and procure new equipment. Perform Risk analysis (PFMEA) on changes to or introductions of products and processes. Plan and perform process validations and equipment qualifications (10/0Q/PQ) on new products and processes. Manage tasks and remain on track to ensure that new equipment and processes are released to production on time. Facilitate changes in the factory through the ECO/MCO process Support EBS and contribute in Kaizen events to reduce downtime and improve yield, production output, productivity and quality. Act as a key contributor for resolving CAPAs. Validate outside suppliers and outside tooling (e.g. molds located at a supplier's facility) Generate technical reports. Conduct DOE and apply statistical strategy to confirm acceptable conditions. Resolve technical engineering issues related to components and manufacturing. Identify opportunities to improve equipment reliability and carve out a path to implement changes in a medical manufacturing setting. Train personnel and transfer equipment/products/processes to standard production.

Requirements

Bachelor's degree in an engineering discipline or equivalent; Additional education or certifications are a plus. Preference for chemical engineering or chemical background/experience.
3+ years professional engineering work experience as well as experience working in a medical device (or similarly regulated) manufacturing environment
Must have experience with performing validations on equipment(I0/00/PQ) and processes as well as experience creating professional test report
Experience working with robotic and/or custom automated equipment in a high-volume manufacturing environment
Must reside within a commutable distance to Yorba Linda, CA. This is not a remote role.

Nice To Haves

Knowledge of process validation and production transfer of new products in a regulated industry
Must have knowledge of manufacturing process, specifically if the experience involves processing of small components
Experience in a regulated industry (medical devices) is a plus
Knowledge of GMP and lean manufacturing
Knowledge of SAP software or a similar document management system is a plus
Passion for being a problem solver and doing root cause analysis
Project management skills
Computer skills, including Microsoft Word, Excel, Power Point
Able to work independently as well as in a team
Must have excellent verbal and written communication skills

Responsibilities

Become the hands-on, subject matter expert on all equipment/processes/products at the Nobel Biocare Yorba Linda facility.
Work with the global team on new product introductions and be accountable for local action items to assure that products and initiatives are introduced on-time, problems are minimized and communicated quickly, and products are manufactured efficiently.
Serve as a point of contact for production and machine center managers to resolve product, process, or equipment issues.
Specify and procure new equipment.
Perform Risk analysis (PFMEA) on changes to or introductions of products and processes.
Plan and perform process validations and equipment qualifications (10/0Q/PQ) on new products and processes.
Manage tasks and remain on track to ensure that new equipment and processes are released to production on time.
Facilitate changes in the factory through the ECO/MCO process
Support EBS and contribute in Kaizen events to reduce downtime and improve yield, production output, productivity and quality.
Act as a key contributor for resolving CAPAs.
Validate outside suppliers and outside tooling (e.g. molds located at a supplier's facility)
Generate technical reports.
Conduct DOE and apply statistical strategy to confirm acceptable conditions.
Resolve technical engineering issues related to components and manufacturing.
Identify opportunities to improve equipment reliability and carve out a path to implement changes in a medical manufacturing setting.
Train personnel and transfer equipment/products/processes to standard production.