Manufacturing Engineer II

Our client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s, and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

This position works out of our Temecula, California location in our AVD Vascular business unit. Our solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our products are also utilized by laboratory management to ensure efficiency in their operations.

Our client provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Job description:

The manufacturing engineer will have two primary functions. The engineer will be responsible to support and/or lead sustaining engineering projects for the department. The engineer will serve as primary manufacturing engineer supporting operations in Abbott Vascular Temecula.

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

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.

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.

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

for product/process knowledge and understanding of cause and effect of line and process changes.

potential risk related to product nonconformance. Has knowledge and expertise on product requirements and specifications.

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

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

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

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.

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).

for continuous improvement projects development and execution.

validation activities for new or existent production lines, meeting regulatory requirements. This includes equipment, process, product, test method validations, SCNs, equipment/material obsolescence, GMI initiatives

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

Requirements:

- Min experience: 3 years in commercial manufacturing. Preferably in medical device industry

- BS degree engineering or equivalent

- Experience is using MS office applications

- Experience in line support, Quality systems, CAPA

- Experience in process qualification/validation

- Experience in problem solving using DMAIC or other methodologies

- Experience in Project management

- English proficient

Plus:

- Familiar with CO/CR process

- Familiar with Abbott systems (LHR, viewpoint, sumtotal, blueprint, others)

- Six sigma training

Must be motivated, self starter, organized, and can multitask.

Must have good communication skills (verbal and written)

There is no traveling.

Will require some flexibility on hours (to be aligned with production schedule and line support ME hours)

Will require to stand for extended periods of time (while in the clean room)

This job will be reviewed periodically and is subject to change by management.

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.