|Reference # :||20-11655||Title :||Engineering Manager|
|Location :||Pomona, CA|
|Experience Level :||Start Date / End Date :||11/02/2020 / 11/01/2021|
|The Engineering Manager is part of the Tox business unit and is located at the Immunalysis site in Pomona, CA. The main function of the position is to oversee the engineering department and develop, implement and maintain the manufacturing processes and equipment. This role will interface with R&D overseeing design transfer and ensuring manufacturing readiness of new products, as well as estimate manufacturing cost, determine time standards and make recommendations for tooling and process requirements of new or existing product lines. This role will be responsible for engineering team which will be responsible for all FUE and process validation activities. This role will be responsible for maintaining records and reporting systems for coordination of manufacturing operations.|
This job description will be reviewed periodically and is subject to change by management.
• Oversee Engineering processes that includes refining current processes and scale up, transfer for all New Product Introduction projects ensuring manufacturing readiness.
• Develops manufacturing processes by studying product requirements; researching, designing, modifying and testing manufacturing methods and equipment; conferring with equipment vendors.
• Management oversight for process, manufacturing and validation engineers overseeing all facilities, equipment, utilities and process validation activities (IQ, OQ, PQ, TMV etc.).
• Responsible for maintenance and operation of production equipment to ensure production goals are met reliably, efficiently and cost effectively.
• Ensures all engineering projects, initiatives and processes are in conformance with organization's established policies and objectives.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Drive continuous improvement of processes through implementation of automation technology for manufacturing and quality control.
• Run design of experiments, process capability studies and engineering studies and document results.
• Oversee equipment and material improvements with vendors to improve quality, performance and cost
• Participate in lean activities, and improve manufacturing efficiency by analyzing and planning work flow, space requirements and equipment layout.
• Demonstrates commitment to the development, implementation and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
• Recognized as a top technical/subject matter expert and technical resource.
• Resolves and consults on most complex issues and drives solutions
• Directs efforts of multiple project teams and direct reports.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Interfaces with other departments as necessary to ensure smooth implementation of new processes, and work to facilitate and expedite the production flow.
• Responsible for planning and directing of all aspects of engineering activities related to assigned projects.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• May work with hazardous materials, high voltage and RF Power.
• Perform other duties & projects as assigned.
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
• BS or MS/PhD degree in engineering or related discipline required.
• 10+ years' related manufacturing experience required.
• 5+ years' related experience in medical devices/IVD industry.
• 3+ years' of previous management experience.
• 5+ years' of validation experience.
• Advanced knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO 13485 and CMDR.
• Recognized expert in multiple technological fields of specialization.
• Strong knowledge of machine function, mechanical /electrical or software engineering.
• Typical computer application includes Solid Works, AutoCAD, MS Word, Excel and Project. May include Lab View, PLC and other specialty machine and vision SW.
• Demonstrated problem-solving and troubleshooting skills.
• Experience with development, validation and implementation of automated assembly, packaging and liquid handling equipment.
• Injection molding experience
• Able to work with a variety of people on multiple tasks.
• Organized and detail oriented.
• Ability to work in a team environment.
• Ability to manage employees to achieve a highly efficient, forward thinking organization.
• Be assertive, team-oriented and open-minded, capable of managing his/her own aggressive timelines with minimal supervision.