Abbott 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 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, 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 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 a 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 worldwide and named one of the most admired companies in the world by Fortune. * A company that 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 Pleasanton,CA location in the Heart Failure Division. In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. We are seeking an experienced, high caliber Senior Engineer, Process Development. This position will design and develop manufacturing processes, equipment, and fixtures in order to meet program milestones for the New Product Introduction (NPI) team in the Heart Failure division. Specifically, this role will support the development and validation of laser welding operations. What You'll Work On * Represent the process development team for New Product Introduction (NPI) * Design and develop manufacturing processes, equipment, and fixtures in order to meet new product program schedules while enhancing productivity and product quality. * Execute process validation protocols and reports. Including but not limited to equipment Installation Qualification (IQ), process Operational Qualification (OQ), process Performance Qualification (PQ), and Product Performance Qualification (PPQ). * Drive process improvements and validations through manufacturing implementation, update pFMEAs, and master validation plan as required. * Own "Cost of Goods Sold" (COGS) models relative to material, direct labor, and overhead costs as well as in consideration to manufacturing process yields. * Utilize various statistical tools (DMAIC, Gage R&R, Cp, Cpk, SPC, etc.) to analyze & improve processes, components, & products. * Partner with R&D to ensure adherence to Design for Manufacturability (DFM) principles. * Drive change orders impacting manufacturing process documentation, product structure, product/component specification changes & improvements. * Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams * Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications * Bachelor of Science degree in Mechanical, Biomedical, or Electrical Engineering, or equivalent * Minimum 5 years of relevant engineering experience * Experience in laser welding process development and process validation. * Demonstrated experience with electronic hardware or software systems Preferred Qualifications * Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control. * Previous medical device experience * Experience with running change orders in Windchill product lifecycle management software * Use of Design of Experiments (DOE) in process optimization * Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. * 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 * Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization * Multitasks, prioritizes and meets deadlines in timely manner * Strong organizational and follow-up skills, as well as attention to detail 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 aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $86,700.00 - $173,300.00. In specific locations, the pay range may vary from the range posted.