Senior Manufacturing Process Engineer

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 109,000 colleagues serve people in more than 160 countries.

About Abbott

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our location in Alameda, CA, currently has an opportunity for a Senior Manufacturing Process Engineer. This person will provide process engineering support to contract manufacturers. Develop, implement and maintain integrated systems for medical device production processes. Work with other engineers to provide accurate and timely resolution to production issues. Work with various internal and external organizations as required to develop manufacturing processes ensuring proper product transfer to contract manufacturers. Develop/maintain configuration and process documentation. Develop, review and perform validation activities for contract manufacturing processes. Review and analyze production data to determine the primary factors affecting product quality, yield and cost.

WHAT YOU'LL DO
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Responsible for implementing and maintaining the effectiveness of the quality system through the application of CAPA systems and GMP.
  • Analyze manufacturing processes and recommend changes and improvements that contribute to scrap reduction, cost reduction, production efficiency and regulatory compliance.
  • Document packaging materials and configurations to assure proper change control.
  • Generate documentation which is compliant with FDA and other regulatory requirements.
  • Generate and release accurate and complete BOMs as required.
  • Assure that product configuration related and process issues are communicated to the responsible areas.
  • Assist in achieving timely resolutions.
  • Support product launches as required by driving completion of product packaging configurations and full documentation release in a timely manner.
  • Support the generation and review of validation reports.
  • Support installation, operational and performance validation activities as required.
  • Drive cost reduction efforts through process improvement activities and product packaging reconfiguration.
  • This position is primarily accountable to 1) Take part in the verification and update of required configuration and process documentation for new manufacturing products, 2) Contribute in periodic reviews of the effectiveness of manufacturing processes in search of improvements, 3) Support the introduction of new product lines, 4) Participate in the achievement of product cost reduction, manufacturing yield, scrap, and cost targets, 5) Assist in the transfer of information required to implement and maintain effective manufacturing processes.
  • Successful implementation of the responsibilities of this position contribute to the effective and efficient production of the highest quality products and support the Abbott QSR requirements.


EDUCATION AND EXPERIENCE YOU'LL BRING
  • Bachelors Degree in a related technical field with 5 years of experience in a mid to high volume manufacturing environment or Masters Degree in a related technical field with 3 years of experience.
  • BS in an engineering discipline (Industrial Engineering preferred) is required to ensure proper technical knowledge to address technical problems.
  • Medical device manufacturing experience required.
  • Working knowledge of manufacturing systems (desired).
  • Ability to use standard PC applications including word processor, common spreadsheets, and database applications such as Agile or MACPAC.
  • Knowledge of FDA regulations and ISO 13485 standards.


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

ABLAUS30991446ENUSEXTERNAL