Senior Manufacturing Process Development Engineer

Thornton Tomasetti; Saint Paul (MN); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Career development

Medical coverage

Retirement plan

Tuition reimbursement

FreeU education

Job summary

Abbott in St. Paul, MN is seeking a Manufacturing Process Development Specialist to design and develop manufacturing processes for life sciences products.

You will work within the Vascular Devices division, contributing to transfer of technology from research to manufacturing. The role requires 4+ years of engineering experience, strong knowledge of design controls, and proven ability to operate in an FDA-regulated environment with GxP understanding.

Qualifications

• Bachelor's degree in Engineering/Technical discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience.
• Master's Degree (± 18 years).
• Minimum 4 years relevant experience.
• Solid knowledge of general engineering principles.
• Good knowledge of design controls and regulations for medical device development (ISO134851, ISO13485, FDA).
• Experience in development in FDA-regulated environments with GxP understanding.

Responsibilities

• Designs and develops manufacturing processes for life sciences products.
• Develops procedures for economical mass production with pilot-plant and production departments.
• Conducts tests and measurements to control variables.
• Troubleshoots production process problems with existing equipment.

Skills

Mechanical engineering

Chemical engineering

Electrical engineering

Physics

Education

Bachelor's degree in Engineering/Technical discipline

Master's degree

Tools

Statistical analysis

Tolerance analysis

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 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.

What You’ll Work On

• 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.

Required Qualifications

Education: 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). 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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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: Manufacturing DIVISION: AVD Vascular LOCATION: United States > Minnesota > St. Paul : 1225 Old Highway 8 NW ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours 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.

EGO 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.