Process Development Engineer ll at Abbott

St Paul, Minnesota, United States

Abbott Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries

Requirements

  • 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
  • Ability to perform in a quality system environment

Responsibilities

  • Design and develop manufacturing processes, tooling, and fixtures to meet new product program schedules, enhancing product quality and considering technology transfer from research to manufacturing
  • Utilize methodologies and statistical analyses (e.g., DMAIC, Gage R&R, Cp/Cpk, SPC) to analyze and improve processes, components, and products
  • Work with cross-functional teams (R&D, Quality, Operations, Regulatory) and 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, overhead costs, and 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 IQ, OQ, PQ, and 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
  • Make recommendations concerning the acquisition and use of new technological equipment and materials

Skills

Process Development
Catheter Systems
Medical Devices
Manufacturing Processes
Engineering
Vascular Devices

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.
Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.
Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.
Abbott's microfluidic devices streamline diagnostic processes efficiently.
Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.
Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.
Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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