Scientist- Research and Development (Biocompatibility) - Military Veterans

Job Summary
The R&D Scientist is responsible for contributing to the development and support of products and technologies within the R&D group and Medline. The role will be a subject matter expert with working knowledge in the evaluation and application of medical device standards and guidelines such as ISO 10993, FDA and EU MDR. Areas of focus will include device evaluation of performance tests, chemical characterization etc., in order to provide product biocompatibility toxicological/risk assessments.

Job Description

Major Responsibilities:

• Plan and execute or otherwise facilitate testing required in support of a product safety and claims.
  
• Author, review, and approve test protocols, evaluation plans 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. Interpret product issues and requests in order to compile technical evaluations and/or justifications and data summaries in support of new and existing product claims and/or changes.
  
• Identify and support the development of product requirements, performance attributes, and quality specifications.
  
• Coordinate verification and validation activities.
  
• Review and trend results to identify product or process improvement opportunities and lead implementation efforts.
  
• Ensure compliance of all data collection and evaluation activities with applicable regulatory requirements.
  
• 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
  

Qualifications:

• Education Bachelor's degree in Chemistry, Biology, or related science field Work Experience 7+ 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.
  

Preferred Qualifications:

• Chemical Characterization Experience: Familiarity with the principles and methodologies used in identifying and quantifying chemical constituents in medical devices, especially for respiratory, wound care, and long-term use devices, and conducting subsequent risk assessments.
  
• Knowledge of Extractables and Leachables (E&L) Analysis: Understanding of E&L studies, including the evaluation of volatile organic compounds, and familiarity with the use of advanced analytical techniques such as GC-MS, LC-MS, and ICP-MS for chemical analysis and subsequent toxicological risk assessments.
  

Additional: Willing to travel up to 10% of the time for business purposes (domestic and international).

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:
$115,440.00 - $173,160.00 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.

Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here .

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.