Associate Engineer Manufacturing

The Opportunity

Our Vascular business develops innovative, minimally invasive, and cost-effective products for the treatment of coronary and peripheral vascular disease.

The Associate Manufacturing Engineer will serve as the primary manufacturing engineer supporting operations in Abbott Vascular Temecula.

The individual performing this role will have to integrate with the team supporting the manufacturing line including but not limited to: the line supervisor, Quality Engineer and operators to address the opportunities found in their assigned manufacturing line. They will be accountable for quality, safety, product output and yield for their assigned manufacturing line. This person may also have a contributing role as a sustaining engineer for the department

What You’ll Work On

• Responsible for the daily support to the manufacturing activities in order to meet established goals for safety, quality, cost, and production.

• Maintains systems that support the monitoring of key performance indicators such as yield, nonconforming material or lead time. If indicators show an adverse trend, works with the functional team to plan and implement appropriate changes.

• Works with line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and support generation of ER, if needed.

• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

• Responsible for product/process knowledge and understanding of basic cause and effect of line and process changes. Understands potential risk related to product nonconformance. Has knowledge and expertise on product requirements and specifications.

• Stays current. Keeps aware of the changing technical and competitive environment as it relates to the business; establishes a means of keeping abreast with technology on own engineering area and sharing with co-workers, e.g., stays current in product/process innovations in areas of expertise.

• Assures that production lines output meet the specifications of the product.

• Has clear criteria of conforming/ non conforming product and the on-line and reliability test methods used for verifying product conformance.

• Maintains manufacturing documentation such as manufacturing process instructions, lot history records, bill of materials.

• Investigates, conducts test or experiments, gathers data, performs preliminary analysis, and reports findings. Prepares and communicates recommendations and respective action plans.

• Leads root cause analysis efforts for basic/simple manufacturing events, utilizing DMAIC model and A3s. Supports CAPA (Major) investigations with data gathering and analysis as needed.

• Line support representative for related projects such as yield improvements, Cost Improvement Project “CIP's”, productivity, quality and safety. Responsible for providing the line with related Engineering solutions, such as tooling (TLTs) and Manufacturing Aids ( from idea definition to implementation). Responsible for simple continuous improvement projects development and execution. Evaluates ideas from the Localized Process Improvement “LPI” program for potential implementation. Reviews existing layouts and standards and creates a proposed design, e.g., uses appropriate tools to complete design drawing/layout; designs a simple piece of equipment or system; modifies an existing design to meet a new need.

• Performs validation activities for new or existent production lines, meeting regulatory requirements. This includes equipment, process, product and test method validations.

• Support maintenance technicians and supervisors in equipment availability issues. Review equipment work order completion and performs product impact analysis in order to release equipment for commercial manufacturing use.

• Assists in the training of personnel required for the operation of equipment.

• Responsible for working with Quality Assurance “QA” counterpart and determining quality impact of Out-of-Tolerance “OOT“ situations.

• Responsible for execution of line-related change management (material, equipment and process changes). Responsible for change order “CO” and simple Change Request “CR” generation related to changes impacting the manufacturing line.

• Complies with all regulations and standards for Quality, Environment, Health, Safety and Energy (EHS&E) Global Policies, Abbott Engineering Standards, and other governance areas as applicable.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree in relevant field.

• Minimum 1 year

• Up to 3 years of experience, both overall and any industry-specific experience needed.

• Knowledge and proficiency in the application and principles of Manufacturing & Process Engineering.

• Ability to effectively communicate cross-functionally to assist in resolving Quality/Engineering issues.

• Excellent written, verbal and interpersonal communication skills.

• Knowledge of common office applications: Word, PowerPoint, Excel.

• Ability to interact effectively with all employee job levels.

• Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

• Basic understanding of materials, product design, product testing.

• Preferred: basic understanding and knowledge of statistics, GD&T, tolerance stack up analysis, Statistical Process Control “SPC”, fundamentals of Design of Experiments “DOE” and problem solving methodologies

• Preferred: familiar with the use of various inspections tools including but not limited to: pin gauge, caliper, micrometer, snap gauge, drop gauge, block gauge, optical comparator, vision system, etc.

• Preferred: experience working in a medical device manufacturing environment such as: extrusion, injection molding, laser cutting, cleaning, passivation, electropolishing, assembly, bonding, packaging, testing, inspection methods, and others.

• Preferred: experience working in a broader enterprise/cross-division business unit model preferred. 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.

• Preferred: experience use of statistical software (ex: Minitab, JMP), six sigma training and/or certification, use of Solidworks (or similar CAD software), MS project, Verification & Validation activities, basic understanding of FDA, Good Manufacturing Practice “GMP” and ISO guidelines.

• Ability to travel approximately 5%, including internationally.