Senior Sterility Assurance Engineer

Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment. In this role, you’ll be responsible for the global Biosafety (Biocompatibility, Sterilization and Cleaning) of medical device activities, working with operations and research groups to develop new products and support continuous quality improvement initiatives, ensuring manufacturing cleanliness, sterility and biocompatibility compliance.

What You’ll Do:

• Act as a subject matter expert for product development teams and manufacturing, benchmarking against industry leaders in the Medical Device industries and regulatory requirements

• Possess knowledge of a variety of microbiological concepts, practices, and procedures related to the application of cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin and biocompatibility analysis of orthopedic implants and surgical instruments.

• Manage the testing conducted by external laboratories according to procedures and standards regarding maintenance of manufacturing cleanliness and sterility compliance, reprocessing activities (cleaning and sterilization) and biocompatibility
• Ensure cleanroom environmental control for air, surface and particle viability in accordance with applicable standards, in addition to control of facilities, including all grades of water and compressed air where necessary (internal or external)
• Ensure coordination of samples for biocontamination control, bacterial endotoxin, sterility, cytotoxicity and chemical residue testing
• Interpretation of sampling and monitoring data, application of statistical and analytical techniques to determine control and trends
• Complete document of external origin gap assessments as needed for reprocessing activities (cleaning and sterilization) and biocompatibility
• Maximize the biocompatibility of products using industry guidelines and advanced testing technologies 
• Review and approve microbiological testing data ensuring compliance to the applicable methods and regulatory standard requirements 
• Work cross-functionally to support new product development and changes to product and/or processes
• Lead and participate in the development and improvement of processes for existing and new products 
• Participate in change control board activities and regulatory audits (FDA, BSI, etc.) as needed 
• Execute quality initiatives that support compliance to standards as well as identifying opportunities for improving and enhancing the processes
• Perform microbiology, sterilization, biocompatibility, and chemical assessments and evaluations for new product introduction, design changes, sustaining and process changes/improvements
• Perform process validations and equipment qualifications
• Develop, maintain and improve internal procedures and SOP’s / Work Instructions with respects to newly evolving and changing standards and regulatory environment
• Drive and support NC/CAPA activities within area of expertise 
• Collaborate with the Quality team to ensure comprehensive support for cleaning, sterilization, and laboratory testing activities, including product release
• Coach, mentor and train functional groups as needed (new hire onboarding, good manufacturing practices) in sterilization and microbiology control areas
• Build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices 
• Perform other duties as assigned or apparent

 

What You Bring:

• Bachelor of Science in an engineering or scientific discipline, such as Biology, Microbiology and Toxicology
• 2 years experience in medical device and/or pharmaceutical manufacturing, sterilization, microbiology, cleaning, sterilization, toxicology, validation, product development, or quality
• 2+ years of applied experience in chemical testing, research and development, or sterility assurance experience
• Knowledge of fundamentals of one or more of the following sterilization techniques: irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, dry heat, or another modality
• Ability to use ISO, AAMI, USP, ANSI, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives
• Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures
• Toxicology knowledge desired
• Demonstrated competency in advanced testing technologies
• Demonstrated ability to manage workload
• Ability to effectively work cross-functionally
• Demonstrated communication skills across different organizational levels
• Results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met
• Demonstrated ability to technically mentor microbiologists, engineers and scientists
• Ability to move medical device products weighing up to 25 pounds
• Strong and effective communication, maintaining relationships and support to cleaning service providers, sterilization and testing labs

 

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and shape strategy in the dynamic field of medical sales—positioning yourself to influence growth and innovation across the organization.

Compensation:
Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $100,000.00 - $115,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.

Benefits include:

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company