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Sterilization Engineer

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Abbott Laboratories

8d ago

  • Job
    Full-time
    Senior Level
  • Engineering
    Healthcare
  • Austin

AI generated summary

  • You should have a relevant engineering degree, 6+ years of experience, knowledge of ISO/FDA regulations, strong mechanical/chemical skills, and experience in medical device development.
  • You will maintain and validate manufacturing processes, optimize equipment, develop specifications, conduct reviews, and ensure compliance with medical standards while collaborating with cross-functional teams.

Requirements

  • 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 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.
  • Working in cross functional team environments is required.

Responsibilities

  • Maintain, develop and validate advanced manufacturing processes and equipment, in accordance with applicable medical regulatory standards. 25%
  • 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. 25%
  • 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. 25%
  • 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. 25%
  • Write and submit Engineering Change Orders, as require.
  • Ensures that processes and equipment meet all applicable standards.

FAQs

What is the role of a Sterilization Engineer at Abbott?

The Sterilization Engineer leads the resolution of process engineering problems related to sterilization specific to medical devices, develops equipment and instruments for complex assembly and testing, and identifies innovative solutions for manufacturing systems.

What are the primary responsibilities of a Sterilization Engineer?

Key responsibilities include maintaining and validating manufacturing processes and equipment, performing process and equipment improvements, developing specifications and conducting analyses, communicating in cross-functional teams, and ensuring compliance with applicable standards.

What qualifications are required for this position?

A Bachelor's degree in engineering or a technical discipline, a minimum of 6 years of related work experience, solid knowledge of engineering principles, and strong technical experience in mechanical or chemical engineering are required.

What is the preferred experience or knowledge for this role?

Preferred qualifications include knowledge of sterilization principles, experience with medical device development regulations, and understanding irradiation sterilization processes, particularly related to diabetes strips.

Is there an opportunity for career development at Abbott?

Yes, Abbott provides career development and growth opportunities with an international presence, allowing employees to pursue their career aspirations.

What benefits does Abbott offer to employees?

Benefits include free medical coverage in the Health Investment Plan, a strong retirement savings plan, tuition reimbursement, and programs supporting educational advancement, among others.

Where is this position located?

The Sterilization Engineer position is based in Buffalo Grove, IL, within the Abbott Diabetes Care Division.

What is the salary range for this position?

The base pay for this position ranges from $85,300.00 to $170,700.00, and may vary in specific locations.

What skills are necessary for effective communication in this role?

Strong written and verbal communication skills are essential for collaborating with cross-functional development teams and effectively relaying technical information.

Does Abbott prioritize diversity and inclusion in the workplace?

Yes, Abbott is committed to employee diversity and has been recognized as a great place to work in various countries for its inclusive environment.

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Abbott Laboratories

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, Abbott serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. More than 115,000 of us are helping millions of people to live better and healthier, every day around the world. Our employees do work that matters as part of a global community that supports them with career development opportunities and locally competitive benefits. Mission: We help people live better and healthier with our life-changing technologies. We're revolutionizing health with the most personal technologies, empowering people with the data and knowledge they need to help them live longer and better.

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