Senior Manufacturing Process Engineer

Abbott (abbottcareers2 board); United States; On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Temecula, CA, is seeking an engineer to develop new manufacturing processes and equipment for medical devices. You will work in the Abbott Vascular Devices division, ensuring regulatory compliance and quality standards.

The role requires strong engineering expertise, cross-functional collaboration, and experience with design controls, GxP, ISO, and FDA guidelines in a development/manufacturing setting.

Qualifications

• Bachelor's degree in Engineering or technical discipline.
• Master's degree is ideal.
• Minimum 4 years relevant engineering experience.
• Strong knowledge of design controls and medical device regulations (ISO 13485, FDA).
• Experience in mechanical or chemical engineering with strong communication skills.
• Familiarity with FDA/GxP, ISO and processes for development/manufacturing of medical devices.

Responsibilities

• Specify, design, verify and validate new manufacturing processes/equipment per medical standards.
• Troubleshoot process equipment; optimize processes.
• Develop process/product specs; conduct pFMEAs, DOEs; prepare validation docs.
• Communicate effectively; participate in cross-functional teams.
• Lead design reviews for equipment and product requirements.
• Submit Engineering Change Orders as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes following FDA guidelines.

Skills

Mechanical engineering

Chemical engineering

Good communication

Cross-functional teamwork

Process optimization

Statistical analysis

Education

Bachelor's Degree in Engineering/Technical field

Master's Degree (ideal)

Tools

pFMEAs

DOEs

Job description

JOB DESCRIPTION:

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.

Working at Abbott

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 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.

Responsible for developing new manufacturing processes, equipment and materials for use in production of medical devices. Works on process engineering problems of diverse scope Exercises judgment and defines methods and criteria in conducting process engineering experiments and reports results Develops networks with internal/external working relationships in area of expertise

What You'll Work On

• Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.
• Troubleshoots process equipment and perform process optimization.
• Develops process/product specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participates in technical design reviews for process equipment and product design and requirements documents.
• Write and submit Engineering Change Orders, as required.
• Responsible for utilizing and maintaining the effectiveness of the quality system.
• Development and implementation of new processes, equipment, materials, verification and validation Follow approved Design Control procedures for process development in accordance with FDA guidelines.

Required Qualifications

Education:

• Bachelors Degree (± 16 years)
• Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)
• An equivalent combination of education and work experience
• Masters Degree (± 18 years) Ideal

Experience:

• Minimum 4 years Relevant experience
• Solid knowledge of general Engineering principals.
• Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.
• Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips.
• Experience in all of the following: performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.
• Writing process/product requirements and design specifications.
• Working on a development team with an emphasis on minimizing time to market.
• Design for manufacture of low cost, high volume electronic products.
• Development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
• Cross functional team environments is required.

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

The base pay for this position is $78,000.00 - $156,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Engineering

DIVISION: AVD Vascular

LOCATION: United States > Temecula : Building E - TE

ADDITIONAL