Operations Engineer

2 days ago

Livermore, United States Advanced Bifurcation Systems Inc. Full time

Position Summary

Reporting to the Director, Engineering & Operations, the Operations Engineer will have responsibility for key aspects of ABS’ product manufacturing and operational processes. Assuming the dual roles of that of a Manufacturing Engineer and Facilities Engineer, the Operations Engineer will work on simple-to-complex, high visibility/value projects with a focus on supporting production. The Operations Engineer will also support the Facilities function in a multitude of ways - compliance, procedure development, equipment maintenance, organization and much more.


Qualifications

• B.Eng in Mechanical Engineering, Industrial Engineering, Manufacturing, or related discipline.

• Prior experience in a manufacturing engineering role within the medical device industry is highly desirable.

• Knowledge of tooling design, assembly processes, and material handling systems.

• Experience in developing and maintaining testing equipment and procedures.

• Knowledge of pFMEA and validation (IQ/OQ/PQ).

• 1-3 years of relevant experience. 


Responsibilities

The range of responsibilities include but not limited to the design, implementation, and maintenance of efficient and scalable systems for production and testing at ABS. The incumbent will collaborate with cross functional teams to reduce defects, improve process capability, and enhance overall operational efficiency. The incumbent will identify operational issues and address them through data-driven evaluations and problem-solving methodologies. The incumbent will demonstrate good working knowledge of applicable safety and quality standards and regulations. Core responsibilities include:


• Serve as the technical resource for production operations, providing guidance and support to the production team.

• Assist or lead production activities including serving as a product builder to fulfil manufacturing needs at ABS.

• Assist with development/improvement of processes and/or workflows to standardize manufacturing operations at ABS.

• Assist with development/improvement of workstations, tools, equipment, and material handling systems, to optimize production efficiency and safety for ABS’ assembly and manufacturing processes.

• Create, review and approve equipment qualification protocols/reports, product/process specifications, analytical method qualifications, process validation strategies/protocols/reports.

• Perform data analysis, evaluate results, forming conclusions and contributing to design, process or documentation improvements. 

• Perform regular maintenance and troubleshooting of production equipment to minimize downtime and ensure optimal safety and performance.

• Maintain oversight of other facilities/utilities related activities. 

• Identify opportunities for new technology and drive continuous improvement.

• Build relationships, initiate and cultivate open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport.

• Interact effectively with stakeholders at appropriate levels of the organization.

• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.

• Assist in training personnel to processes associated with manufacturing and facilities.

• Other duties and responsibilities as mutually agreed. 


Attributes

• Innovative, Creative, Team Player.

• Strong written and verbal communication skills.

• Ability to analyze production data, and implement process improvements.

• Ability to work in a rapidly changing and evolving environment.

• Working knowledge of analytical tools and CAD software (e.g., SolidWorks).

• Working knowledge of applicable regulations and standards (FDA, ISO).


Physical Demands

Business travel from 0% - 20%. Requires some lifting and moving of up to 40 pounds. Required to frequently stand, walk, sit, and use a computer for extended periods. Specific vision abilities required by this job include close/distant vision and depth perception. Position also requires use of Personal Protective Equipment, as needed.







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