Senior Manufacturing Process Development Engineer

Abbott Laboratories•St. Paul, MN
•$78,000 - $156,000•Onsite

About The Position

This specialist professional individual-contributor role is based in St. Paul, Minnesota, in Abbott’s Vascular Devices division. It focuses on manufacturing process development for life sciences products, including designing and developing new or revised processes and addressing challenges involved in transferring technology from research to manufacturing. The role requires comprehensive expertise and the ability to execute highly complex or specialized projects, adapt established approaches, and develop solutions that may depart significantly from traditional methods. The engineer develops procedures for economical mass production in cooperation with pilot-plant and production departments; conducts tests and measurements throughout production to control relevant variables; and troubleshoots and resolves problems with processes or equipment already in operation. The role also involves recommending new technology and materials where appropriate and applying an understanding of compliance and relevant pharmaceutical, biological, medical, patent, and commercial factors. The position supports Abbott Vascular, which develops minimally invasive and cost-effective products for treating vascular disease.

Requirements

  • Bachelor’s degree in an engineering or technical discipline, or an equivalent combination of education and work experience; mechanical, chemical, electrical engineering, or physics preferred.
  • Minimum of 4 years of relevant experience.
  • Solid knowledge of general engineering principles.
  • Good knowledge of design controls and regulations for medical device development, including ISO 13485 and FDA requirements.
  • Strong technical experience in mechanical or chemical engineering, with excellent written and verbal communication skills.
  • Strong understanding of processes and materials used in medical-device development and manufacturing, particularly diabetes strips.
  • Experience performing complex engineering calculations and relating results to controlled tests, including statistical and tolerance analysis.
  • Experience working in a development environment using a disciplined process/product development process.
  • Experience writing process/product requirements and design specifications.
  • Experience working on development teams with an emphasis on minimizing time to market.
  • Experience with design for manufacture of low-cost, high-volume electronic products.
  • Experience developing processes in an FDA-regulated environment, with understanding of GxP, ISO, and medical-device regulations.
  • Experience working in cross-functional team environments.

Nice To Haves

  • Master’s degree (identified as ideal).

Responsibilities

  • Design and develop manufacturing processes for life sciences products, including new or revised processes.
  • Address challenges in transferring technology from research to manufacturing.
  • Develop procedures for economical mass production in cooperation with pilot-plant and production departments.
  • Conduct tests and measurements throughout production to establish control over applicable variables.
  • Service, troubleshoot, and solve problems with production processes or equipment already in operation.
  • Apply relevant compliance, pharmaceutical, pharmacological, biological, biochemical, medical, patent, and commercial considerations.
  • Make recommendations concerning the acquisition and use of new technological equipment and materials.

Benefits

  • Career development opportunities with an international company.
  • Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • Retirement savings plan with high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit, providing an affordable and convenient path to a bachelor’s degree.
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