R&D Specialist, Biocompatibility

Medline Industries, LP

23h • $79,000 - $119,000

About The Position

Responsible for contributing to the development of new products and technologies within the R&D group. The role will be a subject matter expert in a specific support area and will facilitate project needs related to that knowledge. Areas of focus may include performance testing, chemical characterization, stability testing, biocompatibility, toxicological assessments, risk assessments, etc.

Requirements

• Bachelor’s degree in Chemistry, Biology or related science field.
• At least 2 years of experience in a medical device or pharmaceutical related field.
• 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).

Responsibilities

• Plan and execute or otherwise facilitate testing required in support of a product claim.
• Author and review test protocols and reports.
• Track, compile, and review all results needed in support of product requirements and regulatory submissions such as 510k’s, CE technical files, and ANDA/NDAs.
• Compile technical justifications and data summaries in support of product claims.
• Identify and support the development of product requirements, performance attributes, and quality specifications.
• Coordinate verification and validation activities.
• Ensure compliance of all data collection activities with applicable regulatory requirements.
• Participate in the support of internal and external audits.
• Compile risk assessments, identify gaps, and propose solutions.
• Lead process improvement, CAPA, OOS investigations, and data trending activities.
• Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• 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 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level