Danaher Corporation Sterilization Engineer in Raleigh, North Carolina
Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you’re collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team.
Be part of a company that’s a trusted leader in breast cancer diagnostics and support products you can feel passionate about!
Mammotome is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
Are you a Sterilization Engineer that wants to support products you can be passionate about? Join our diverse team of dedicated people and be inspired to grow every day!
You will provide technical expertise to Engineering, R&D, Sustaining and Operations in sterilization and microbiological areas. Collaborate with multi-functional teams to lead and execute required studies to ensure product reliability and patient safety for Mammotome’s sterile single use and reusable products.
We are open to remote work from any continental U.S based major city with access to an international airport.
Collaborate with Design Engineering, Manufacturing, Marketing, Regulatory, Supplier and Design Quality functions to define sterilization requirements for new product development, Sustaining, CMO and VAVE design changes
Plan and perform sterilization assessments and validations for single use-sterile devices using Gamma, E-beam radiation and/or EO methods, compiling with ISO 11137 and ISO 11135
Plan and carries out cleaning, disinfection, sterilization validations for reusable devices in compliance with ISO 17664 and applicable region standards
Coordinate microbiological testing with approved laboratories to support project teams
Document Sterilization validation requirements, draft and release test protocols, reports, cleaning, disinfection and sterilization processes
Collaborate with Regulatory to generate Sterilization sections for product regulatory submissions and address questions from the FDA, Notified Bodies, SFDA (China), MFDS (Korea), and PMDA (Japan) on regulatory submissions and audits
Bachelors’ degree in a technical field such as Microbiology, Biomedical Engineering, Bio Engineering, Material Science Engineering, Chemical Engineering, Physical Science or Life Sciences with specific coursework in Microbiology
2+ years of related experience in medical device or tissue sterilization (Radiation or Ethylene Oxide) or hospital sterile processing in a technical role
Knowledge of ISO 11137/ISO 11135 or 21 CFR Part 820/1270/1271 or ISO 13485 Design Controls required
Experience or familiarity with reprocessing of reusable devices
Project Management experience
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.