Senior Manufacturing Process Development Engineer

The Opportunity

This position works out of our Portland, OR location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

MAIN PURPOSE OF ROLE:

• Specialist professional individual contributor with comprehensive knowledge in the area of Manufacturing Process Development.

• Ability to execute highly complex or specialized projects.

• Adapts precedent and may make significant departures from traditional approaches to develop solutions.

What You’ll Work On

• As the Specialist in the Manufacturing Process Development Sub-Function, considered a highly experienced and knowledgeable resource within the organization in designing and developing manufacturing processes for life sciences products, taking into consideration problems inherent in the transfer of technology from research to manufacturing.

• Such design and development may include new or revised processes.

• Develops procedures for the economical mass production in cooperation with the pilot plant and production departments.

• Conducts tests and measurements throughout stages of production to determine control over applicable variables.

• Services, troubleshoots, and solves production process problems with processes or equipment already in operation.

• Requires understanding of compliance, pharmaceutical, pharmacological, biological, biochemical, medical, patent, and commercial factors.

• May make recommendations concerning the acquisition and use of new technological equipment and materials.

Required Qualifications

• Bachelor's degree in engineering field

• 7+ years of related experience

Preferred Qualifications

• Medical Device experience

• Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304.

• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)