Engineer II

Company Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities: 

• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Establishes programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
• May write training material and conduct training sessions on quality control activities.
• May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative applications.
• Meeting with cross-functional team members, component drawing reviews developing inspection methods & fixturing, reviewing/analyzing data, tracking & reporting on status, validation protocol/execution/reports – for fixtures & test methods, supplier meetings, supporting supplier process validations, supporting receiving inspection issues (MRBs, NCRs, etc.), creating & releasing qualification reports, inspection measurement plans, SOPs, inspection process sheets.
• The first device is a novel highly complex (>50 parts) system inclusive of a delivery system and a permanent implant. They need to be able to apply the first principles of engineering and understand how material properties impact stress and strain response, they must understand tolerance stack-up and how to design for anticipated production variance.
• The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems, and processes and develop quality standards. A typical quality engineer can read and interpret blueprints and evaluate product integrity and standards.
• Typical office hours: exact start and stop times can be flexible. This role will be full time onsite at the Irvine campus.

 Requirements:

• Bachelor's degree in engineering required.
• 2-4 years of experience required.
• Project & time management/organization/planning, Minitab/data analysis, problem solving.
• Inspection development, Risk management, SolidWorks/Creo, Six Sigma.
• Creativity, verbal and written communication skills, analytical and problem-solving ability.
• Team player and detail oriented.
• Basic ability to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
• Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).

Additional Information

All your information will be kept confidential according to EEO guidelines.