Manufacturing Process Engineer

Abbott • Temecula, CA

7d • Onsite

About The Position

Abbott is hiring an experienced Manufacturing Process Engineer for its Abbott Vascular Devices division, based at its distribution site in Temecula, California. The role works under limited supervision and applies subject matter knowledge in medical device and manufacturing engineering to meet specific needs and requirements. Abbott Vascular develops minimally invasive, cost-effective products for treating vascular disease.

The engineer implements and maintains manufacturing processes, develops process flow sheets and models process operations, and prepares equipment specifications and operating instructions. The role also supports production testing, troubleshooting, process and equipment problem-solving, regulatory compliance, and, potentially, corrective and preventive actions and investigation management. The position requires manufacturing support experience, including work with drug delivery systems, drug products, combination devices, and quality and regulatory systems.

Requirements

• Bachelor’s degree in Chemical or Biochemical Engineering, Polymer Sciences or Engineering, Mechanical Engineering, Biomedical Engineering, or Science, with the posting also describing a Master's degree plus three years of relevant experience as an acceptable pathway.
• Three to five years of Process Engineering or Operations experience with a bachelor's degree, or a master's degree plus three years of Process Engineering or Operations experience.
• Experience in process and equipment development and optimization for small drug molecules and polymer-based drug delivery systems.
• Experience with late-stage or commercial products, with a strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and monitoring, scale-up, and/or technology transfer, including PFMECA and DFMECA.
• Strong knowledge of quality systems, drug product manufacturing, and process validation.
• Work history involving cGMPs, regulatory filings, and compliance issues for drug products and combination devices.
• Strong organizational, leadership, teamwork, written communication, and verbal communication skills.
• Demonstrated ability to work enthusiastically and proactively in a highly matrixed team environment.

Responsibilities

• Implement and maintain manufacturing processes.
• Calculate and organize data for complex process flow sheets, including instrumentation and control considerations.
• Model processes and unit operations.
• Ensure the proper sequence of operations and prepare specifications and operating instructions for processing equipment.
• Conduct tests and measurements throughout production to monitor variables such as temperature, density, pressure, and viscosity.
• Service, troubleshoot, and solve engineering problems involving processes or equipment already in operation.
• Ensure processes and procedures comply with regulations.
• May manage corrective and preventive actions and investigations.

Benefits

• Career development opportunities with an international company.
• Employees may qualify 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, an affordable and convenient path to earning a bachelor's degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level