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Job Description:

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 plant 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.

Job Requirements:

Qualifications:

+ Bachelor'sdegreeinanengineeringdiscipline or equivalent; Additionaleducation orcertificationsareaplus.Preference forchemicalengineeringorchemical background/experience.

+ 3+ years professional engineering work experience as well as experience working in a medical device (or similarly regulated) manufacturing environment

+ Must haveexperience with performing validations onequipment(I0/00/PQ)and processes as well as experience creating professional test report

+ Experience workingwithrobotic and/or custom automated equipment ina high-volume manufacturing environment

+ Must reside within a commutable distance to Yorba Linda, CA. This is not a remote role.

Preferred Skills:

+ Knowledgeofprocessvalidationandproductiontransferofnewproductsinaregulatedindustry

+ Musthaveknowledgeofmanufacturingprocess,specificallyif theexperience involvesprocessingof small components

+ Experienceinaregulatedindustry (medicaldevices)isaplus

+ KnowledgeofGMPandleanmanufacturing

+ KnowledgeofSAPsoftwareorasimilardocumentmanagementsystemisaplus

+ Passionforbeingaproblemsolveranddoingrootcauseanalysis

+ Projectmanagementskills

+ Computerskills,includingMicrosoftWord,Excel,PowerPoint

+ Abletoworkindependentlyaswellasinateam

+ Musthaveexcellentverbal andwrittencommunicationskills

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$83,400 - $118,200

Operating Company:

Nobel Biocare

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.

Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .