Manufacturing Engineer II

DiaSorin; Cypress (CA); On-site; USD 97,000 - 132,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive

Job summary

DiaSorin Molecular LLC specializes in immunodiagnostic and molecular diagnostics, advancing science to improve patient outcomes. This Manufacturing Engineer II role focuses on evaluating and optimizing production processes, leading validations, and ensuring FDA/ISO compliance to deliver consistent, high-quality products.

Ideal candidates hold a Bachelor’s in engineering and have 2+ years in IVD/related industries, with ASQ certification preferred.

Qualifications

• Bachelor's degree in engineering required.
• ASQ Certified Quality Engineer preferred.
• Experience in IVD/medical/pharmaceutical industries preferred.

Responsibilities

• Evaluate and optimize manufacturing processes to improve product consistency, quality and productivity.
• Write and perform validations and validation reports for production equipment.
• Support FDA/ISO and other regulatory requirements.
• Identify, isolate and correct technical challenges to improve product reproducibility.
• Improve processes to reduce costs and scrap.
• Lead transition of new manufacturing technology, including validation and training.
• Coordinate and supervise validations of processes and equipment.
• Represent Operations on cross-functional core teams for new products.
• Support internal and external audits.
• Ensure EHS compliance and safety policies.

Skills

Statistical quality control

Statistical process control

Corrective action

Technical documentation

Cross-functional collaboration

Education

Bachelor's Degree in Mechanical, Electrical, or Industrial Engineering

ASQ Certified Quality Engineer

Job description

Manufacturing Engineer II

Location: Cypress, California, United States

Company: DiaSorin Molecular LLC

Employment type: Regular Full Time

Job Category: Operations

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters: Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale: Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture: Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

Evaluate and optimize Manufacturing processes to improve product consistency, quality and to increase productivity. Write and perform validations and validation reports for production equipment as necessary. Support all applicable regulations including but not limited to FDA, ISO requirements.

Job Responsibilities and Duties

• Work with Production and Technical Support personnel to identify, isolate and correct technical challenges for improving product reproducibility.
• Improve Production processes to reduce production costs and decrease scrap.
• Research and purchase new manufacturing technology including automated equipment to improve production using project management tools.
• Implement the transition of new manufacturing technology to ensure production continues successfully. This includes leading the validation and PCR effort as well as any training necessary.
• Coordinate and supervise required validations of processes and equipment.
• Improve and implement new processes.
• Participate on cross-functional core teams for new products to represent Operations and Manufacturing Engineering.
• Participate to support both internal and external audits.
• Maintain and increase work flow.
• Interact with all required departments to assist with project completion.
• Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
• May delegate and coordinate workload for technician group as needed. Responsible for enforcing all EHS policies in their span of control.
• Perform other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree in an engineering discipline such as Mechanical, Electrical or Industrial Engineering, Required
• 2+ Years with BS - related experience in IVD, medical, pharmaceutical, or other related industry, Required Or
• 1+ Years with MS- related experience in IVD, medical, pharmaceutical, or other related industry, Required
• ASQ Certified Quality Engineer, Preferred.
• Preferred understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool
• 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 from calculus and statistics.
• 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

What we offer

The hiring range for this position is $97,300 - $131,700 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].