Sr Process Development Engineer

Description

Summary: Serve as a Sr Process Development Engineer supporting manufacturing operations, focusing on quality, output, and yield, while acting as a subject matter expert and mentor. Highlights: 1. Lead engineering initiatives and support manufacturing operations 2. Be a subject matter expert in site products and processes 3. Coach and mentor less experienced engineers Apply Now Abbott is a global healthcare leader th helps people live more fully 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 115,000 colleagues serve people in more than 160 countries. Working Abbott At Abbott, you can do work th mters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an internional 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 a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU educion benefit - an affordable and convenient ph to getting a bachelor’s degree. A company recognized as a gre place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company th is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Santa Clara, CA locion in the SH division. Structural Heart Business Mission: Why We Exist. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treing structural heart disease. As the Sr Process Development Engineer, you will serve as the primary engineering personnel supporting manufacturing operions. The individual performing this role will have strong collaborion with the line supervisor, Quality Engineer and operors to address all the opportunities found in the assigned manufacturing line. This role will be accountable on quality, output and yield of the assigned manufacturing line. Will also serve as the engineering management representive in the manufacturing line, executing initiives and working directly with the DL workforce. This person may also have a role beyond the line support engineering as a sustaining engineer for the department. As a Senior Engineer, this person is one of the most experienced and expected to be subject mter expert in the site products and process. Wh You’ll Work On Responsible for assigned line output, safety, yield and quality. Responsible for identificion of product defects and determinion of operional and process reled actions to reduce the defects. This may also include equipment trouble-shooting and sub-sequent work order request. Works with line support team (QC supervisor, Mfg. Supervisor, Quality Engineer and Operions) to perform on line issue triage to evalue issues and determine if non-conformance is present, determine initial bracketing and containment, and genere corrective actions/preventive actions as needed. Responsible for product/process knowledge and understanding of basic cause and effect of line changes. Considered and expert in stistics, product and Engineering process. Responsible for modeling/drafting assemblies; fixtures & tools; Solidworks mid to advance level. Responsible for providing the line with reled Engineering fixes, such as tooling (TLTs) and manufacturing aids (from idea definition to implemention). Knowledgeable of procedures reled to equipment controls. Support technicians and supervisors in equipment availability issues. Supports Training and Certificion Program. Provides additional insight on how to improve trainings and certificions in the best interest of the business. Responsible for determining quality impact of Out-of-Tolerance documents. Responsible for execution of line reled change management (merial, equipment and process changes). Responsible for CO and CR generion reled to modere to complex changes impacting the manufacturing line. Responsible for continuous improvement projects development and execution, including CAPAs implementions. Responsible for exception subtask execution. Evalues ideas for continuous improvements. Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s. Leads CAPA (Major) investigions with da ghering and analysis as needed. Owns CAPA activities without oversight. Runs studies and validions on the line as needed. Be the ME representive for manufacturing reled projects including yield, CIP's, productivity, quality and safety. Responsible for coordinion of product builds through the NPI process. Generes all types of changes to the eLHR system. Leads ME support during external and internal audits. Acts as coach and mentor to more inexperienced engineers or technical personnel. Leads stistical analysis for complex events the site. Can genere qualificion and validion protocols and reports with minimal oversight. Owns basic to medium to high complexity CR activities with no oversight. Demonstres comprehensive understanding of regulions in area of work and where to look for informion. Considered SME for most Engineering mters. In conjunction with RA: - Understands regulory implicions of proposed changes. - Understands wh types of changes require filings. Completes documention to support regulory filings with oversight. Minimal oversight required for problems or assignments of reasonable difficulty. Makes decision in an efficient manner, even when having limited informion. Considers risk mitigion in planning based on lessons learned or from peers. Reviews previous similar projects and activities as part of the decision-making process. Anticipes potential situions th may impact projects timeline and resolves them before they become an issue. Prepares and provides well thought out contribution to meetings. Provides technical guidance to peers th facilites the progression of the project, group or person. Can present informion and collabores with peers across functions (both internally and externally). Exposure to cross functional mgmt. communicions. Leads manufacturing engineering projects of high complexity, including CIPs, CAPA, Validions. May have delegion authority for area manager. Required Qualificions Bachelors Degree (± 16 years) in Engineering reled field. Minimum 5 years experience. Basic knowledge of applicable US non-US applicable regulions. Knowledge and proficiency in the applicion and principles of Manufacturing/Process Engineering. Ability to effectively communice cross-functionally to assist with resolving Quality/Engineering issues. Cheter assembly experience is required. Process Validions experience is required. Excellent written, verbal and interpersonal communicion skills Ability to interact effectively with all levels of employees. Knowledge of common office applicions: Word, PowerPoint, Excel. Knowledge of stistical analysis. 3-D drawing (Solidworks required). Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com Follow your career aspirions to Abbott for diverse opportunities with a company th can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us www.abbott.com, on Facebook www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $90,000.00 – $180,000.00. In specific locions, the pay range may vary from the range posted. Apply Now