Senior Manufacturing Process Engineer
Abbott
Summary
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.
Job description
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.
Requirements
- Bachelors Degree in Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)
- Minimum 4 years relevant experience
- Solid knowledge of general Engineering principals
- Good knowledge of design controls and regulations for medical device development (ISO13485, FDA)
- Strong technical experience in mechanical or chemical engineering
- Excellent written and verbal communication skills
- Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips
- Experience performing complex engineering calculations and relating results to controlled tests, including statistical analysis and tolerance analysis
- Experience 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
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.