Process Engineer III

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Diabetes Care in Alameda, CA seeks an engineering professional to design, verify and validate manufacturing processes for diabetes care products. You will troubleshoot equipment, develop specifications, and run PFMEAs, DOEs and validation reports to meet design control requirements.

Join a team focused on process development, cost-efficient manufacturing and regulatory compliance within an FDA-regulated environment.

Qualifications

• Bachelor's degree in Engineering/Technical Discipline or equivalent.
• 4+ years of related experience in engineering/manufacturing.
• Solid understanding of medical device design controls and regulatory requirements (ISO13485, FDA).
• Experience with development of processes in an FDA-regulated environment.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment, per medical regulatory standards.
• Troubleshoots process equipment and perform process optimization.
• Develops process/product specifications, conducts PFMEAs, DOEs, validation protocols/reports.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participates in technical design reviews for process equipment and product design.
• Write and submit Engineering Change Orders, as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes, equipment, materials verification and validation.
• Follow approved Design Control procedures for process development per FDA guidelines.

Skills

Engineering principles

Regulatory knowledge

Process optimization

Cross-functional teamwork

Documentation writing

Problem solving

Statistical analysis

Design for manufacturing

Education

Bachelor's degree in Engineering/Technical Discipline

Master's degree

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

• 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 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.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Join us at Abbott Diabetes Care (ADC) in our mission to help individuals with diabetes lead active, fulfilling lives. We're focused on helping people manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions.

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.

This is an onsite opportunity based out of Alameda, CA.

Required Qualifications

• Bachelor's degree Engineering/Technical Discipline or an equivalent combination of education and work experience
• 4+ years of related experience
• Solid knowledge of general Engineering principles.
• 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 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 manufacturing 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.

Preferred Qualifications

• Master's degree
• Experience in a mid-volume manufacturing environment, preferably within the medical device industry.

The base pay for this position is $90,000.00 - $180,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Engineering

DIVISION: ADC Diabetes Care

LOCATION: United States > Alameda : 2901 Harbor Bay Parkway

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/