Development Engineering Tech I

Process Development Engineer IIAbbott 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, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.What You'll Work OnResponsible for assigned line output, safety, yield and quality. This may also include equipment trouble-shooting and subsequent work order request.Works with line support team (QC supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform on line issue triage to evaluate issues and determine if non-conformance is present, determine initial bracketing and containment, and generate corrective actions/preventative actions as needed.Considered and expert in statistics, product and Engineering process.Responsible for modeling/drafting assemblies; Solidworks mid to advance level.Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and manufacturing aids (from idea definition to implementation). Knowledgeable of procedures related to equipment controls.Support technicians and supervisors in equipment availability issues.Supports Training and Certification Program. Responsible for determining quality impact of Out-of-Tolerance documents.Responsible for execution of line related change management (material, equipment and process changes). Responsible for continuous improvement projects development and execution, including CAPAs implementations. Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s. Leads CAPA (Major) investigations with data gathering and analysis as needed. Be the ME representative for manufacturing related projects including yield, CIP's, productivity, quality and safety.Leads statistical analysis for complex events at the site.Considered SME for most Engineering matters.In conjunction with RA: - Understands regulatory implications of proposed changes. - Completes documentation to support regulatory filings with oversight.Considers risk mitigation in planning based on lessons learned or from peers. Reviews previous similar projects and activities as part of the decision-making process. Anticipates potential situations that may impact projects timeline and resolves them before they become an issue.Provides technical guidance to peers that facilitates the progression of the project, group or person.Leads manufacturing engineering projects of high complexity, including CIPs, CAPA, Validations.Required QualificationsBachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, biological sciences, or equivalent experience.2-5 years of related work experience with a good understanding of specified functional area.Knowledge and proficiency in the application and principles of Manufacturing/Process Engineering.Ability to effectively communicate cross-functionally to assist with resolving Quality/Engineering issues.Knowledge of common office applications: Word, PowerPoint, Excel.Knowledge of statistical analysis.3-D drawing (Solidworks required).