Senior Engineer, Process Development
AbbottAbout the role
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 .
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- 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.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
THIS IS AN ON-SITE DAILY POSITION.
The Opportunity
This position works out of our Plymouth, MN location in our Electrophysiology Division.
Leading an active lifestyle is important to the many people we serve. We’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in ELECTROPHYSIOLOGY & HEART FAILURE, allowing people to restore their health and get on with their lives.
We are seeking a high caliber Senior Process Development Engineer. Acts as the subject matter expert for the process engineering team and sees products transition from development into full production. Develops processes and implements those into production through thorough validation by working closely with research/development and quality teams.
- Develop processes based on product specifications and in consideration to process and test method capabilities
- Evaluates process and design alternatives based on “design for manufacturability” principles.
- Author and execute Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance
- Qualification (PPQ).
- Understands principles of “Cost of Goods Sold”.
- Solve problems using problem solving and statistical tools and make sound design recommendations.
- Manages program compliance with “Quality Control” requirements (i.e. Design Control, Process validation etc.).
- Understands IP issues relative to processes being developed.
- Maintains knowledge of new developments in manufacturing and design technologies.
- Understand work environment issues (i.e. OSHA regulations, etc.).
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- 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.
EDUCATION/EXPERIENCE
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
- BS degree in Mechanical Engineering or Technical Field or equivalent experience; advanced degree preferred
- 6+ years manufacturing experience - microelectronics assembly experience preferred
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