Senior Manufacturing Process Development Engineer

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

Job summary

Abbott is a global healthcare leader with a Vascular Devices division based in St. Paul, MN.

This Specialist role focuses on Manufacturing Process Development, designing and developing manufacturing processes for life sciences products and ensuring regulatory compliance, with a strong emphasis on cost-effective, scalable production. Ideal candidates bring 4+ years in engineering, strong knowledge of ISO13485/FDA, and a track record of working in cross-functional teams to bring complex devices to

Qualifications

• Bachelor's Degree in Mechanical, Chemical, Electrical or Physics or equivalent.
• Master's Degree preferred.
• Minimum 4 years of relevant experience.
• Strong knowledge of design controls and medical device regulations (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with good written and verbal communication.
• Understanding of processes and materials for medical devices, especially diabetes strips.
• Experience in development in FDA regulated environment with GxP.
• Cross-functional team collaboration.

Responsibilities

• Design and develop manufacturing processes for life sciences products.
• Develop procedures for mass production with pilot-plant and production.
• Conduct tests to control production variables.
• Troubleshoot and solve production process problems.
• Advise on new equipment and materials.
• Ensure compliance with regulatory factors.

Skills

Mechanical engineering

Chemical engineering

Statistical analysis

Design for manufacture

Written communication

Verbal communication

Cross-functional teams

FDA regulations

GxP knowledge

ISO 13485

Education

Bachelor's degree in engineering/technical discipline

Master's degree

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.

WhatYou’llWork 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

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

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.

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