R&D Specialist

Medline•Northfield, MN

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. Job Description 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.

Requirements

Bachelor’s degree in Chemistry, Biology or related science field.
A 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.