Senior Process Development Engineer

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.

JOB DESCRIPTION:

Senior Process Development Engineer - Santa Clara, CA

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 Santa Clara, CA location in the Structural Heart.

What You’ll Work On

• This position will lead studies to develop and optimize processes to improve quality and manufacturability for delivery systems.
• Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency
• Coach, mentor, and provide guidance to other engineers, technicians, trainers, and manufacturing personnel.sewing specialists
• Supports Training Certification Program. Provides additional insight on how to improve trainings and certifications in the best interest of the business.
• Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO & CR generation related to moderate to complex changes impacting the manufacturing line.
• Manage projects which include new production equipment, process development/improvements and cost reductions while supporting new product introductions
• Conduct process FMEAs and process validations
• Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC)
• Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment
• Work cross functionally with R&D, Finance, Quality and Operations to define process inputs and outputs
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Ensure compliance 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.
• Leads root cause analysis efforts utilizing DMAIC model and A3s. Leads CAPA investigations with data gathering and analysis as needed. Owns CAPA activities without oversight

What You'll Bring:

• Bachelor’s degree in industrial, or Mechanical Engineering, or other related discipline
• 5+ years manufacturing engineering experience in medical device or related industry, including working on and documenting process improvement initiatives
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Previous experience working in a highly matrixed and geographically diverse business environment
• Strong analytical, problem solving, and project management skills
• Strong organizational and follow-up skills, as well as attention to detail
• Individual should be innovative, resourceful, and work with minimal direction
• Individual should have excellent organization, problem solving, communication, and team leadership skills
• Proficient with MS Office (Word, Excel, Outlook, PowerPoint)
• Ability to travel approximately 510%, including internationally
• Demonstrated record of implementing LEAN processes, working with R&D on specification assessments, new product introduction/development experience, working jointly with Quality for process and inspection improvements, working jointly with Regulatory on submission requirements and working with Finance to drive cost all while improving quality via RTG and CIP initiatives.

Preferred Qualifications:

• Medical device experience
• Previous close interface with R&D preferred
• Previous surgical and/or transcatheter tissue heart valve experience in design and driving yield improvements, reducing cost, while increasing capacity
• Lean 6 Sigma Green or Black Belt certification

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 X @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.

JOB FAMILY:Engineering

DIVISION:SH Structural Heart

LOCATION:United States > Santa Clara : Building A - SC

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:Yes, 5 % of the Time

MEDICAL SURVEILLANCE:No

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf