Process Engineer III

Abbott; Alameda (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Healthcare plan

Retirement plan

Tuition reimbursement

Job summary

Abbott Diabetes Care (ADC) in Alameda, CA is hiring a Process Engineer III to support on-site manufacturing equipment and processes. You will lead upgrades, support cost reduction and quality improvements, and guide project teams with regulated manufacturing practices.

The role requires a strong background in mechanical or chemical engineering, knowledge of ISO/FDA design controls, and experience in development environments focused on medical devices, including diabetes strips.

Qualifications

• Bachelor’s degree in engineering/technical discipline or equivalent.
• 4+ years of related experience in medical device engineering.
• Solid knowledge of general engineering principles.
• Knowledge of design controls and regulatory standards (ISO13485, FDA).
• Experience with mechanical or chemical engineering and strong communication.
• Experience with FDA-regulated environments and GxP.
• Cross-functional team collaboration.
• DFM, high-volume electronics development.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment per medical regulatory standards.
• Troubleshoot process equipment and optimize processes.
• Develop process/product specifications, perform pFMEAs, DOEs, validation protocols and reports.
• Communicate with cross-functional development teams.
• Conduct design reviews for process equipment and product design requirements.
• Submit Engineering Change Orders as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes, equipment, materials, verification and validation.
• Follow FDA Design Control procedures for process development.

Skills

Bachelor’s degree

4+ years experience

Engineering principles

Design controls

Regulations

Mechanical engineering

Chemical engineering

Communication skills

Medical devices materials

Statistical analysis

Tolerance analysis

Requirements specs

Time-to-market

DFM / high volume electronics

FDA regulations

Cross-functional teamwork

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

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 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.

Process Engineer III provides engineering support for new and existing equipment and processes used in T manufacturing operations. This role develops and implements equipment upgrades and modifications to reduce product costs and improve product quality, participates in and leads project teams requiring engineered solutions for new equipment, products, or processes, and implements, documents, and maintains controlled, repeatable production processes.

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

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

• 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.