Process Development Engineer

Process Development Engineer IIAbbott 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.At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: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 contributionTuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.This position works out of our Plymouth, MN location in the EP division.In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.We are seeking a Process Development Engineer II to join our dynamic team at our Plymouth, MN facility. This role is ideal for an engineer who thrives in a hands-on, fast-paced environment and is passionate about driving innovation, improving manufacturing processes, and ensuring product quality in a regulated industry.As a Process Development Engineer II, you will play a critical role in the development, optimization, and validation of manufacturing processes. Your work will directly impact product quality, operational efficiency, and regulatory compliance.Key responsibilities include:Process Development & Implementation: Lead the design, development, and implementation of new manufacturing processes and equipment. Specify, acquire, and validate new equipment to support production and process improvements.Problem Solving & Root Cause Analysis: Apply structured problem-solving methodologies to identify root causes of process issues. Develop and implement corrective and preventive actions (CAPAs).Data-Driven Improvements: Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams. Drive continuous improvement initiatives to enhance product quality, reduce waste, and increase efficiency.Documentation & Compliance: Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions. Ensure all processes comply with internal quality systems and external regulatory requirements.Cross-Functional Collaboration: Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up. Provide technical training and mentorship to technicians and junior engineers.Innovation & Technical Leadership: Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities. Support tooling development and process validation for new and existing products.Required qualifications:Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field) with 2–5+ years of relevant experience OR master's degree with 0–2 years of experience or an equivalent combination of education and experience.Strong analytical and problem-solving skills.Proficiency in technical writing and documentation.Ability to work independently and collaboratively in cross-functional teams.Excellent communication and presentation skills.Working knowledge of manufacturing systems, automation, and process control.Preferred qualifications:Experience in the medical device industry, particularly with catheter manufacturing or similar regulated environments.Familiarity with GMP, ISO 13485, and FDA regulations.Hands-on experience with process validation, DOE, and statistical analysis.The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.Job Family: EngineeringDivision: EP ElectrophysiologyLocation: United States > Minnesota > Plymouth : 5050 Nathan Lane NWork Shift: StandardTravel: Yes, 15% of the TimeMedical Surveillance: NoSignificant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.