Senior Manufacturing Process Engineer (on-site)

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

The Senior Manufacturing Process Engineer provides technical and sterilization engineering support in a manufacturing area including activities such as cycle development, process validation and equipment qualification. This new team member recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products. This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. This individual will work on-site at our Temecula manufacturing site.

• Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.  Provide guidance and training to other engineers, technicians and operators.  Additional responsibilities include: Provide technical mentorship to engineers and technicians. Conduct Process FMEAs and Process Validations. Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts. Coordinate the design, procurement, build and debug of tooling, machinery and test equipment.  Work with Product Development to ensure Design for Manufacturability.
• Draft, review or execute verification / validation protocols, identify validation risks and impacts.
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP, and all other applicable agency regulations.
• Coordinate select and schedule technicians and operators for operations tasks and projects
• Implement and manage resource planning and project management tools
• Monitor and evaluate project and department progress and results
• Conducts CAPAs for sterilization non-conformances and biological indicator sterility positive investigation.
• Supports activities associated with support for sterilization qualification for new and/or existing products utilizing Radiation, Ethylene Oxide, V-H2O2, and novel sterilization technologies.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.  Networks with key contacts outside own area of expertise.
• Leads Continuous Improvement activities including Problem Solving Tools, Lean, Six Sigma, Management Operating Systems, Visual Factory, Suggestion Programs and Metric Tracking
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Individual should: Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.

• Bachelor’s degree in Mechanical, Chemical or any Engineering or technical field degree
• Minimum of 5 years of experience, both overall and any industry-specific experience.
• Strong analytical, problem solving and project management skills. 
• Experience in manufacturing engineering experience, medical device experience required. 
• Demonstrated leadership capability in team settings.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. 
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner. 
• Strong organizational and follow-up skills, as well as attention to detail.

• Experience with Medical Device products, manufacturing/process development experience with minimum of 4 years of people management.
• Experience with statistical techniques (i.e. DOE, SPC) as well as Lean manufacturing technique, value stream mapping, and continuous improvement methodologies. Solid knowledge of GMP and ISO regulations.
• Experience working in a broader enterprise, cross division business environment,
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• International manufacturing experience.
• Six Sigma certification. 
• Experience working in a broader enterprise/cross-division business unit model.

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