Manufacturing Process Engineer

Abbott Laboratories • Temecula, CA

4d • $61,300 - $122,700 • Onsite

About The Position

The Manufacturing Process Engineer works under limited supervision at Abbott’s distribution site in Temecula, California, within the Abbott Vascular Devices division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treating vascular disease. The role applies subject-matter knowledge in medical device and manufacturing engineering to implement and maintain processes, applying skills and knowledge to specific needs and requirements.

The engineer develops and optimizes processes and equipment, supports manufacturing of late-stage or commercial products, and helps ensure processes and procedures comply with regulations. The role may also involve responsibility for corrective and preventive actions and investigation management.

Requirements

• Bachelor’s degree in Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or Science; alternatively, a master’s degree with the stated experience.
• With a bachelor’s degree, 3–5 years of Process Engineering or Operations experience; alternatively, a master’s degree plus 3 years of Process Engineering or Operations experience.
• Experience developing and optimizing processes and equipment for small drug molecules and polymer-based drug delivery systems.
• Knowledge of 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; PFMECA and DFMECA experience.
• 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 medical device and 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 during production to monitor variables such as temperature, density, pressure, and viscosity.
• Service, troubleshoot, and resolve engineering problems involving operating processes or equipment.
• Ensure processes and procedures comply with regulations.
• May manage corrective and preventive actions and investigations.

Benefits

• 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, offering an affordable and convenient path to a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

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