R&D Specialist, Medical Device Stability

Job Summary The R&D Specialist will work with internal business partners and product development teams to provide stability support. This role is responsible for writing stability protocols/reports, evaluating stability data, performing risk assessment, and supporting process improvements. This position plays a critical role in setting expiration dates for medical devices, drugs, and cosmetics.

Job Description

Responsibilities: Direct stability studies required in support of product claims. Determine the tests and acceptance criteria required for stability in collaboration with testing subject matter experts and product divisions. Support new product development and provide stability requirements. Author and review test stability protocols and reports. Evaluate and trend stability data. Compile technical justifications and data summaries in support of stability claims. Ensure compliance of all data collection activities with applicable regulatory requirements. Participate in the support of internal and external audits. Support process improvement, deviations, CAPA, and OOS investigations. Qualifications: Bachelor of Science in Chemistry, Biology or related field. At least 2 years of experience in a medical device or pharmaceutical related field. Knowledge / Skills / Abilities Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes. Knowledge of CE technical files. Experience with risk assessment and root cause analysis. Experience solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists. Experience communicating with internal and external business partners and cross functional teams with various audiences. Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills. Position may require travel up to 10% of the time for business purposes (domestic and international). Preferred Qualifications: Experience with stability studies for medical devices in a regulated environment. Knowledgeable of stability indicating medical device testing requirements per FDA guidelines and ASTM standards ISO 11607 knowledge as it pertains to performance and stability testing parameters Protocol/Report and LIMS experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com. Apply tot his job Apply To this Job