Senior Manufacturing Process Engineer

Thornton Tomasetti; United States; On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Temecula, CA is seeking a process engineer to develop and optimize manufacturing processes for vascular devices. You will design, verify and validate equipment and processes in a regulated FDA environment.

The role requires strong analytical skills, experience with PFMEAs/DOEs, design controls, and cross-functional teamwork. Excellent communication and problem-solving are essential as you drive quality and efficiency.

Qualifications

• Bachelor's or Master’s in Engineering, relevant experience preferred.
• Regulatory knowledge: FDA, ISO13485, ISO134851/13485.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment per medical standards.
• Troubleshoot process equipment and perform process optimization.
• Develop process/product specifications, conduct PFMEAs, DOEs, validation protocols/reports and other documentation.
• Communicate effectively and participate on cross functional development teams.
• Maintain and improve quality system effectiveness through controlled change management.

Skills

Statistical analysis

Tolerance analysis

DFM

Cross-functional team

Regulatory knowledge

Education

Bachelor's Degree in Engineering

Master's Degree preferred

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.

JOB DESCRIPTION: 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.

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 LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Yes SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.