Manufacturing Process Engineer

Abbott; United States; On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott Vascular is seeking an Experienced Manufacturing Process Engineer to work at the Temecula, CA distribution site. You will apply subject matter knowledge in Medical Device and Manufacturing Engineering to develop and maintain processes under limited supervision.

Responsibilities include data-driven process flow, modeling, and ensuring regulatory compliance while driving continuous improvement and CAPA investigations in a matrix team environment.

Qualifications

• Bachelor's degree or higher in a relevant engineering/science field.
• Minimum 3 years of process engineering or operations experience.
• Experience with Six Sigma, risk analysis, process validation, scale-up and technology transfer.
• Knowledge of cGMPs, regulatory filings and compliance issues for drug product and combination devices.
• Excellent organizational, leadership, teamwork, written and verbal communication skills in a matrix environment.

Responsibilities

• Implement and maintain manufacturing processes for Medical Device and Manufacturing Engineering.
• Calculate and organize data for complex process flow sheets including instrumentation and control considerations.
• Model processes and unit operations to optimize performance.
• Ensure proper sequence of operation and prepare equipment specifications and operating instructions.
• Conduct tests and measurements to control variables like temperature, density, pressure and viscosity.
• Troubleshoot, service and improve processes or equipment in operation.
• Ensure processes comply with regulatory requirements and participate in CAPA investigations.

Skills

Leadership

Teamwork

Data analysis

Documentation

Education

Bachelor's degree in Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or Science

Tools

PFMECA

DFMECA

Job description

Working at Abbott

Abbott 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 122,000 colleagues serve people in more than 160 countries.

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our distribution site in Temecula, CA location in the Abbott Vascular Devices division.

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

Experienced Manufacturing Process Engineer that works under limited supervision.

Applies subject matter knowledge in the area of Medical Device and Manufacturing Engineering.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

What You'll Work On

• As the Experienced professional in Medical Device and Manufacturing engineering, possesses well developed skills in implementing and maintaining processes.
• Calculates and organizes all data for complex process flow sheets including instrumentation and control considerations.
• Models processes and units operations.
• Ensures proper sequence of operation and prepares specifications and operating instructions for processing equipment.
• Conducts tests and measurements throughout stages of production to determine control over such variables as temperature, density, pressure and viscosity.
• Services, troubleshoots, and solves engineering problems with processes or equipment already in operation.
• Ensures processes and procedures are in compliance with regulations.
• May be responsible for corrective and preventive actions and investigation management.

Required Qualifications

Education

Bachelors Degree (± 16 years)

Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or Science

Experience/Background

Minimum 3 year

Bachelor's Degree 3-5 years of Process Engineering or Operations experience OR a Master's Degree + 3 years of Process Engineering or Operations experience.

• Process/equipment development and optimization experience in small drug molecules and polymers based drug delivery systems.
• Knowledge of late stage or commercial products experience with strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
• Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues for drug product and combination devices.
• Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $61,300.00 - $122,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Engineering

DIVISION

AVD Vascular

LOCATION

United States > Temecula : AWDC

WORK SHIFT

Standard

TRAVEL

Yes, 5 % of the Time

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT 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), Keyboard use (greater or