Senior Manufacturing Process Development Engineer

Abbott • Saint Paul, MN

17h • Onsite

About The Position

This position works out of our St. Paul, MN location in the Abbott Vascular Devices division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. The Opportunity 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. As the Specialist in the Manufacturing Process Development Sub-Function, considered as 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 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 acquisition and use of new technological equipment and materials.

Requirements

• Bachelors Degree (± 16 years) Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience
• Masters Degree (± 18 years)
• 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.
• 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.

Responsibilities

• Designing and developing manufacturing processes for life sciences products, taking into consideration problems inherent in the transfer of technology from research to manufacturing.
• Developing new or revised processes.
• Developing procedures for economical mass production in cooperation with pilot-plant and production departments.
• Conducting tests and measurements throughout stages of production to determine control over applicable variables.
• Servicing, troubleshooting, and solving production process problems with processes or equipment already in operation.
• Making recommendations concerning acquisition and use of new technological equipment and materials.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior