Manufacturing Engineer II: Optimize & Validate Processes

DiaSorin; Cypress (CA); Presencial; USD 97.000 - 132.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Statistical quality control

Statistical process control

Corrective action

Technical documentation

Cross-functional collaboration

Educación

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

ASQ Certified Quality Engineer

Descripción del empleo

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.