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 nutritionals and branded generic medicines. Our 114000 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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution

• Tuition reimbursement theFreedom 2 Savestudent debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelors 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 Abbotts Vascular business unit. This is a fully onsite role.

What Youll 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

• Bachelors degreeoran equivalentcombination of education and work experience.

• 2 years of related medical device experience

• Working technical knowledge and application of conceptspracticesand 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.

• Exercisesjudgment within defined procedures and practices to determineappropriate action.

• Has a broad knowledge of technical alternatives and an understanding of their impact on thesystemsenvironment.

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