Sr. Scientist Microbiology & Sterilization Analytics
Elkton, MD, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Senior Scientist, Microbiology and Sterilization Analytics is responsible for authoring high quality technical documentation, conducting complex data analysis, and supporting quality engineering initiatives within the Sterility Assurance and Laboratory Operations team. This role integrates microbiology and sterilization sciences to drive data-informed decisions and ensure compliance with regulatory requirements. The Senior Scientist collaborates across multiple functions and sites, providing technical support in a multidisciplinary environment.
Job Details/Responsibilities
- Develop, write, and review technical protocols and reports related to microbiological testing, environmental monitoring, and sterilization validation.
- Analyze and interpret complex data sets from microbiology and/or sterilization studies to support trend analysis, annual reviews, program optimization activities, and technical projects.
- Collaborate with cross-functional teams including Quality, Regulatory, Engineering, and Manufacturing to ensure alignment on technical content and project timelines, as applicable. Supports new product development and design change/change control projects.
- Support internal and external audits by preparing documentation, responding to observations, and participating in audit readiness activities.
- Apply quality engineering principles to assess risk, drive continuous improvement, and ensure compliance with applicable technical standards (e.g., ISO 14644, ISO 11737, ISO 11135, ISO 11137, etc.).
- Revise and maintain standard operating procedures, work instructions, and best practices for departmental areas.
- Conduct root cause investigations and manage nonconformances and CAPAs related to the areas of microbiology and sterilization.
- Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
Knowledge, Skills and Abilities (KSA)
- Scientific and analytical rigor, critical thinking
- Attention to detail and documentation accuracy
- Cross-functional collaboration
- Regulatory and compliance mindset
- Effective communication (written and verbal)
Qualifications/ Background Experiences
- Bachelor’s degree in Microbiology, Biomedical Engineering, Chemistry or related scientific field.
- Minimum of 8 years of relevant experience which may be combination of sterility assurance, microbiology, chemistry/R&D and quality engineering, with at least 3 years of direct experience in a sterility assurance/microbiology function.
- Strong technical writing skills with demonstrated experience in authoring scientific protocols and reports.
- Proficiency in data analysis tools (e.g., Excel, Minitab) and statistical interpretation.
- Working knowledge of sterilization methods (e.g., EO, radiation) and microbiological principles (e.g., contamination control, controlled environments, bioburden and bacterial endotoxins testing).
- Experience supporting audits and working within a regulated environment (FDA, ISO, etc.).
Preferred:
- Experience with quality engineering tools (e.g., FMEA, CAPA, root cause analysis).
- Familiarity with regulatory submission processes (e.g., 510(k), PMA).
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay: $94,800 - $130,350/year