Responsible for daily support to manufacturing activities in order to meet established goals for safety, quality, yield, and attainment.
Maintains systems that monitor key performance indicators, such as yield, nonconforming material, and attainment.
Works with the functional team to plan and implement appropriate changes if indicators show an adverse trend.
Works with Operations support team (supervisor, engineers, operators, technicians) to investigate potential non-conformances, determine initial bracketing and product containment, and support generation of non-conforming material reports, if needed.
Responsible for product/process knowledge and understanding of basic cause-and-effect of line and process changes.
Has knowledge of product requirements and specifications.
Understands clear criteria of conforming/ non-conforming product and the test/inspection methods used for verifying product conformance.
Maintains manufacturing documentation such as process instructions, test & inspection methods, and form packets and updates through change control process as needed.
Investigates adverse trends in line performance and reports findings.
Prepares and communicates recommendations and action plans.
Leads root cause analysis efforts for basic/simple manufacturing events, utilizing DMAIC model and A3s.
Supports CAPA investigations with data gathering and analysis as needed.
Assists in ideation and implementation of new fixturing and tooling for manufacturing line.
Supports validation activities for new or updated equipment or processes, including writing of qualification protocols/reports, equipment specifications, and preventative maintenance procedures.
Supports maintenance technicians in equipment availability issues.
Reviews equipment work order completion and performs product impact analysis to release equipment for manufacturing use.
Assists in the training of Operations and Maintenance personnel.
Owns Out-of-Tolerance reports for manufacturing equipment and works with Quality Engineering to determining product impact.
Assists with Manufacturing Investigation of adverse product events in the field.
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.
Requirements
Bachelors Degree or relevant experience
0-3 years of experience
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(If required).
Benefits
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Manufacturing EngineeringProcess EngineeringRoot Cause AnalysisDMAICStatistical Process ControlDesign of ExperimentsTolerance Stack Up AnalysisProduct TestingQuality EngineeringValidation Activities
Soft skills
CommunicationOrganizational SkillsAttention to DetailMultitaskingPrioritizationInterpersonal SkillsTeamworkProblem SolvingFollow-up SkillsAdaptability
Certifications
Six Sigma TrainingFDA ComplianceGood Manufacturing PracticeISO Guidelines