Quality Engineer - Sterilization

Job Description

Job Description Job ID: MAM000728
About Us
At Mammotome, we are committed to providing best-in-class technology to help clinicians accurately diagnose breast cancer. We provide clinicians devices spanning the breast cancer diagnostic care continuum from tissue biopsy to accurate lesion removal, never forgetting that at the heart of each breast cancer diagnosis is the patient. Through our ever-expanding product portfolio we strive every day to improve the patient’s journey and achieve better outcomes. Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world.
Description

Sterilization Engineers are responsible for providing expert technical/business leadership to engineering teams and operations in area of sterilization and functioning as a Mammotome technical expert in sterilization and microbiological areas. This position will also evaluate technical and regulatory requirements against business needs in development and maintenance of corporate level policies, procedures and strategies impacting all Mammotome’s sterile single use and reusable products, facilities and contractors.

RESPONSIBILITIES

• Owner of sterilization process and all associated questions for new product development projects and design changes
• Responsible for programs for microbiological testing and biocompatibility testing.
• Systematically improves products through implementation of quality management specifications, procedures, test methods, and measurement systems.
• Develop new and/or improved techniques for engineering tasks.
• Develops risk management plans, reports, and utilize risk management tools such as FMEAs and FTAs.
• Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN).
• Works with Manufacturing, Marketing, Regulatory and Engineering functions to define requirements for new product development.
• Responsible for the sterilization aspects in the administration of project management and design control.
• Coordinates microbiological testing with approved laboratories to support teams.
• Coordinates expose of test samples to sterilization processes to support teams
• Conducts biocompatibility testing per ISO 10993-1
• Generates biocompatibility assessments for new product development and design changes.
• Conducts gamma, EO, and other sterilization method validations as applicable
• Responsible for sterilization validation requirements in the overall team schedules to ensure team goals are met.
• SME on microbiological issues related to product design.
• Directs development teams and operations on sterilization validation requirements, appropriate test methods and manufacturing environment to meet quality, cost and release to market objectives.
• Directs operations (internal and suppliers) on environmental monitoring practices for manufacturing environments.
• Determines appropriate DDS strategies for complex product / orientations with possible assistance of more senior level engineers.
• Trouble-shoots sterilization process deviations and develops short- and long-term solutions to prevent reoccurrence with possible assistance of more senior level engineers.
• SME on specific sterilization and/or microbiology questions.
• Maintains sterilization programs (dose audits, CME maintenance, EO requalification, etc.).
• Creates management level presentations and writes formal reports.
• May supervise technical personnel to facilitate sterilization validations, troubleshooting or sterilizer operations.
• May assist supplier audit team as SME
• Ensures any contractors can meet sterilization policy requirements.
• Other duties as assigned.

Job Requirements
Qualifications

REQUIRED SKILLS/EXPERIENCE

• Bachelor of Science in Biomedical Engineering, Life Science or Chemical Engineering with specific coursework in Microbiology.

• Equivalent of 3 years of experience and demonstrated proficiency in medical device sterilization.

• Experience in radiation sterilization, ethylene oxide sterilization and microbiology laboratory procedures to work independently or assist more senior level employees in resolving sterilization process issues and coordinating appropriate testing.

DESIRED SKILLS/EXPERIENCE

• Training and experience in Good Manufacturing Practices and ISO.

• Medical device experience.

• Experience or familiarity with reprocessing of reusable devices.

TRAVEL REQUIREMENTS

• Must be able to travel up to 20% of the time; both domestic and international travel may be required.

• Typical work-related travel assignments range 2-5 days, and as such overnight, out-of-town stays are required.

#LI-KL1Diversity & InclusionAt Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.