Process Development Engineer II
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- Lead the design, development, and implementation of new manufacturing processes and equipment.
- Specify, acquire, and validate new equipment to support production and process improvements.
- Apply structured problem-solving methodologies to identify root causes of process issues.
- Develop and implement corrective and preventive actions (CAPAs).
- 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.
- 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.
- 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.
- Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities.
- Support tooling development and process validation for new and existing products.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
