Process Development Engineer I

Abbott-posted 2 months ago
$50,000 - $100,000/Yr
Full-time • Entry Level
5,001-10,000 employees
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This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. 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. Engineer I, Process Development performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

  • Establish processes based on product specifications.
  • Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Design and develop manufacturing tooling and fixtures.
  • Utilize methodologies and statistical analyses, such as DMAIC, Gage R&R, Cp/Cpk and SPC, to analyze and improve processes, components and products.
  • Understand principles of Cost of Goods Sold.
  • Manage program compliance with Quality Control requirements (i.e. Design Control, Process validation etc.).
  • Maintain knowledge of new developments in manufacturing and design technologies.
  • Author and execute validation protocols and reports including installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and process performance qualifications (PPQ).
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Bachelors Degree Engineering or Technical Field OR an equivalent combination of education and work experience.
  • 0-2 years engineering experience.
  • Medical Device experience preferred.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel including internationally (if required).
  • Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with 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.
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