Stryker
Location
Salt Lake City, UT | United States
Job description
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team:
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting
Stryker is hiring a Staff Microbiologist in Salt Lake City, Utah, to support Neurovascular! In this role, you will be primarily responsible for the sterility compliance of Stryker’s product in accordance with relevant regulatory requirements and standards for medical devices. You will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilization processes and associated utilities.
We're looking for someone to lead the setup of our microbiology lab, focusing on optimizing processes and enhance our capabilities!
Who we want:
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Collaborative Partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do:
Working within the microbiology team, you will ensure effective and efficient sterility practices, which includes, but not limited to the following:
Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bioburden and endotoxin testing.
Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending.
Leads NC and CAPA generation and resolution within the Microbiology group and across related business units.
Act as technical lead for microbiology in cross functional groups including product and process issues, root causing, projects, initiatives and other business critical forums.
Applying cGLP to all laboratory activities including stock control.
Performing sampling for validations and re-qualifications as required. Review of validation files for compliance.
Interact with Supplier quality team with respect to vendor sterility topics.
Performs sterility release review, interpreting data and trends. Common methods include Ethylene Oxide Sterilization and Gamma Ray Sterilization.
Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards.
Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
Support of, ensure compliance of new products to sites’ sterility standards. Ensure successful integration of products into validated processes.
Ensures biocompatible of components, materials and consumables used in the manufacture of Stryker product.
Provides Technical Assessment for completion of Risk Assessment in the area of sterility and microbiology.
Demonstrates knowledge of the business processes and products across multiples sites.
Mentors and trains team and cross functional groups as required.
What you need :
Required
Bachelor’s degree in Microbiology or a related discipline i.e., Biomedical Engineering, Biology, Genetics, Engineering, etc.
4+ years’ experience as a Microbiologist (Cleaning, Disinfection, Biocompatibility, or Sterilization) in a regulated industry.
Preferred
Demonstrate technical supervisor capabilities and leads projects to completion.
Strong competency in troubleshooting, correction of NC and root cause analysis.
Our benefits:
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
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