DiaSorin Molecular is dedicated to infectious disease diagnostic testing services, products, and information. We are focused on diagnostic solutions that can help improve the health of patients and populations that can help improve the world.
JOB TITLE: Operations – Process Engineer III
Legal Entity: DiaSorin Molecular LLC
Organizational Area: USA & Canada
Country / State: USA - CA
Place of Work: USA - Cypress, California, USA
Home/Office Based: Office based
Professional Family: Operations
Reporting To: Production Manager, Technical Operations
Kind of contract : Full Time / Permanent
JOB SCOPE | YOUR MISSION
Apply fundamental engineering principles to create practical solutions to technical challenges and provide technical support across functions. Proven skills in the areas of equipment designs, process scale-up from R&D, process improvement of existing processes and implementation of automated control systems. Responsible for evaluating and optimizing processes to improve product consistency and to increase productivity. Support company goals and objectives, policies and procedures and FDA regulations. Responsible to assist in the development and performance of validations on equipment. Supports applicable regulations including ISO13485, Local, State, and/or Federal requirements.
MAIN RESPONSIBILITIES | YOUR CONTRIBUTIONS
Work with Healthcare Diagnostics Group personnel to identify, isolate and correct technical challenges to improving equipment reliability and reproducibility.
Lead improvement initiatives to improve production processes to increase productivity, manufacturing yields, reduce production costs and decrease or eliminate scrap.
Initiate protocol, execute and write final report for equipment and process validations (IQ/OQ/PQ).
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
Proficient in technical writing and writing clear and detailed manufacturing SOPs, Engineering reports, ECRs, and other documents.
Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes.
Lead automation projects to improve quality and reduce scrap.
Troubleshoot manufacturing process and equipment; and provide manufacturing engineering support to resolve production issues.
Work with R&D and Tech Support to help transfer new products into production and ensure that design for manufacturability principles are applied to new processes.
Interact and coordinate activities such as CAPA investigations, and NCRs with Production and QC/QA personnel.
Conduct benefits and cost analysis with regards to capital equipment and generate capital expense documentations.
Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
OTHER INFORMATION AS PER LOCAL LEGAL REQUIREMENTS - USA VACANCIES (ONLY) JOB POSTING REQUIREMENT for USA VACANCIES for DiaSorin Molecular LLC
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future.
It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees.
To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. DiaSorin is an EEO/AA employer. EEO is the Law. www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdfJOB
QUALIFICATIONS, EXPERIENCE, SKILLS & PERSONAL STRENGTHS | YOU
Bachelor’s degree in an engineering discipline such as Bio-Medical, Mechanical, Material or Industrial Engineering with Five – Seven plus years related experience in IVD, medical, pharmaceutical, or other related industry.
Process automation experience strongly preferred. Extensive experience in equipment design and validation specifically with processes related to IVD diagnostic kits.
Must have a thorough understanding of statistical quality control, statistical process control, corrective action process, and their application manufacturing as a problem identification and resolution tool.
Demonstrated experience in application of lean manufacturing principles.
Prefers strong computer skills in Microsoft Office applications, Solid-works, and Minitab.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Certification in Lean/Six-sigma preferred.
While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hand to finger, handle, feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk and hear.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision requirements involve close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
LANUGAGES: Fluent spoken and written English
Additional Salary Information: BENEFITS | WE OFFER YOU
As per local and Company requirements for DiaSorin Molecular LLC.
A competitive compensation package including Medical, Dental, Life, STD, LTD, 401(k) or Roth 401(k) Retirement plan.
DiaSorin Molecular is dedicated to infectious disease diagnostic testing services, products, and information. We are focused on diagnostic solutions that can help improve the health of patients and populations that can help improve the world. Our company has continued to create a culture of innovation, quality, and personalized service, and we enjoy a reputation as a resource for infectious disease understanding that goes beyond the test.