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Abbott · 2 months ago

Process Development Engineer ll

United States - Minnesota - St. Paul

Full-time

Onsite

Entry, Mid Level

$60K/yr - $120K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Process Development Engineer will join the Process Development engineering team to design and develop manufacturing processes for delivery catheter system development in Abbott’s Vascular business unit.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Qualification

Process DevelopmentStatistical AnalysisEngineering DrawingsMedical Device ExperienceCross-Functional CollaborationMultitaskingProblem SolvingCommunication SkillsTeam Leadership

Required

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

Medical Device experience

Benefits

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.