Process Development Engineer ll

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, nutritional’s and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Senior Process Development Engineer

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

Our St Paul, Minnesota location is seeking a high caliber, motivated, self-driven individual to join our Process Development engineering team for delivery catheter system development in Abbott’s Vascular business unit. This is a fully onsite role. 

What You’ll Work On

• Design and develop manufacturing processes, tooling, and fixtures to meet new product program schedules, enhancing product quality and taking into consideration problems inherent in the transfer of technology from research to manufacturing.

• Utilize methodologies and statistical analyses, such as DMAIC, Gage R&R, Cp/Cpk and SPC, to analyze and improve processes, components and products.

• Work with cross-functional teams including R&D, Quality, Operations, and Regulatory teams. Collaborate with R&D to ensure adherence to Design for Manufacturability (DFM) principles.

• Understand principles of Cost of Goods Sold (COGS) including material, direct labor, and overhead costs as well as in consideration to manufacturing process yields.

• Proficient in reading and creating engineering drawings, including dimensions, tolerances, and schematics. 

• Drive process improvements and validations through manufacturing implementation and revise process failure mode effects analyses (pFMEAs).

• Author and execute validation protocols and reports including installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and process performance qualifications (PPQ). 

• Maintain communications with all levels of employees, customers, and vendors.

• Comply with U.S. Food and Drug Administration (FDA) regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• May make recommendations concerning the acquisition and use of new technological equipment and materials.

Required Qualifications

• Bachelor’s degree or an equivalent combination of education and work experience. 

• 2+ years of related medical device experience

• Working technical knowledge and application of concepts, practices and procedures.

• General understanding of business unit/group function.

• Will perform this job in a quality system environment.

• Failure to adequately perform tasks can result in noncompliance with governmental regulations.

• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

• Exercises judgment within defined procedures and practices to determine appropriate action

• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Preferred Qualifications

• Medical Device experience

Additional Qualifications:  

•  Be innovative, resourceful, and work with minimal direction
•  Have excellent organization, problem solving, communication, and team leadership skills
•  Have ability to multitask, priorities their work and make data driven decisions
•    Work effectively with cross-functional teams