Sterilization Engineer

Abbott; Austin (TX); On-site; USD 85,000 - 171,000; Full time

Job summary

An established industry player is seeking a Sterilization Engineer to join their innovative team in Austin, Texas. This role focuses on solving complex engineering challenges related to medical devices, specifically in the diabetes care sector. The engineer will design and develop equipment for assembly and testing, ensuring compliance with regulatory standards. This position offers a unique opportunity to contribute to life-changing technologies that improve health management for individuals with diabetes. Join a company that values growth, diversity, and impactful work while enjoying a range of benefits that support your well-being and career development.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Education benefits

Career development opportunities

Qualifications

• 6+ years of experience in engineering, preferably in medical devices.
• Solid knowledge of design controls and regulations for medical device development.

Responsibilities

• Lead resolution of process engineering problems in Sterilization.
• Maintain and validate advanced manufacturing processes and equipment.

Skills

Engineering principles

Design controls and regulations

Mechanical engineering

Chemical engineering

Statistical analysis

Communication skills

Process/product requirements

Education

Bachelor's degree in engineering/Technical Discipline

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 114,000 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 your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Sterilization Engineer works out of our Austin, TX location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health 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.

What You’ll Work On

The Sterilization Engineer leads resolution of challenging process engineering problems within Sterilization on diverse scope specific to medical devices. Independently leads the design and develops equipment and instruments for use in complex assembly and testing of medical devices. Works independently to identify, design and develop innovative solutions for implementation into irradiator and processes used in volume manufacturing systems. Exercises judgment and defines methods and criteria in conducting process engineering experiments and reports results. Develops networks with internal/external working relationships in area of expertise.

Responsibilities:

• Maintain, develop and validate advanced manufacturing processes and equipment, in accordance with applicable medical regulatory standards.
• Performs process and equipment improvement and optimization. Generates reports on engineering data, analysis and results. Leads and influences cross functional teams for the implementation into pilot and volume manufacturing systems.
• Develops significant process/product specifications, conduct pFMEAs, DOEs, authors characterization and validation protocol, leads execution and authors reports and other associated documentation following design control requirements.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participate in technical design reviews of process equipment and product design and requirements documents.
• Write and submit Engineering Change Orders, as required.
• Ensures that processes and equipment meet all applicable standards.

Required Qualifications

• Bachelor's degree in engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience.
• Minimum of 6 years of related work experience.
• Solid knowledge of general Engineering principles.
• 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.
• Working in cross functional team environments is required.

Preferred Qualifications

• Solid knowledge of general sterilization principles.
• Good knowledge of validation and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong understanding of irradiation sterilization processes and materials used in and manufacturing of medical devices, particularly diabetes strips.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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 $85,300.00 – $170,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Engineering

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Texas > Austin : 12501B Research Boulevard

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day).