Senior Process Development Engineer

Abbott-posted 3 months ago

$75,300 - $150,700/Yr

Full-time • Mid Level

5,001-10,000 employees

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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. The opportunity is for a Senior Process Development Engineer in our Minnetonka, Minnesota location, focusing on delivery catheter system development in Abbott’s Cardiac Rhythm Management (CRM) business unit. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Design and develop manufacturing processes, tooling, and fixtures to meet new product program schedules, enhancing product quality and considering 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).
Provide technical mentorship and direction for junior engineers and ensure timely delivery of program milestones.
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.

Bachelor's degree in engineering field
5+ years of related experience
Strong analytical, problem solving and project management skills
Demonstrated leadership capability in team settings
Ability to lead and motivate peers, drive change and problem solve with creativity.

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

Career development with an international company
Free medical coverage in Health Investment Plan (HIP) PPO medical plan
Excellent retirement savings plan with a high employer contribution
Tuition reimbursement and FreeU education benefit
Recognition as a great place to work in dozens of countries
Paid time off
401(k) retirement savings with a generous company match
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs.

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