Chemist II (REMOTE)
1402 Alton Pkwy Irvine, CA 92606 US
The Client Quality Labs (EQL) provide a comprehensive range of testing and consulting services for safety and biocompatibility evaluation of medical devices. We are looking for a scientist in material science, polymer chemistry, or organic chemistry with expertise in medical device materials to join our high-paced and dynamic team.
This role will support the EQL Continuous Improvement Program, specifically helping to streamline how certain medical device materials are evaluated in new/modified products, as part of an overall risk-based approach. The candidate will apply their expertise in materials chemistry to provide solutions for complex problems and contribute to improvements in process efficiency.
This role requires an organized, proactive self-starter who possesses excellent multi-tasking and communication skills. The candidate must be comfortable interacting with a diverse team ranging from management staff to technical chemists, biologists, toxicologists, and engineers. This is an excellent opportunity to work in leading medical device company developing life-saving products.
This position is a remote 6-9 month contract with the possibility to convert to a permanent role depending on candidate performance and business need.
Essential Job Functions:
- Performing critical review of materials in historical and current Client medical device qualifications, providing insights and enhanced documentation for tested materials. Assist in updating existing procedures to improve guidance for certain types of qualifications.
- Writing material characterization reports for a diverse range of medical devices. These reports assess raw material chemical makeup and manufacturing processes to identify potential chemical extractables, ensure compliance with ISO 10993-18 chemical characterization, and serve as an resource for L&E chemistry and toxicology teams.
- Providing consulting support on questions of materials formulations such as polymeric and metallic products, coatings, polymer additives, pigments/dyes, surface treatment agents, surfactants, solvents, processing aids, etc.
- Assisting in understanding how the constituent materials of Client products interact with a wide variety of chemical treatments, manufacturing processes, and sterilization modalities.
- Providing support to different business units in materials selection and manufacturing, giving guidance on material compatibility with different chemicals and processes.
- Working closely with internal/external product development teams and suppliers to obtain detailed chemical composition and compatibility information for materials.
- Knowledge of common medical device materials, including types of polymer additives, compounded formulations, and metal alloys.
- Knowledge of common medical device manufacturing techniques (e.g. extrusion, injection molding, machining), as well as cleaning and sterilization processes.
- Experience in reviewing materials documentation, including but not limited to SDS, CoA/CoC, technical drawings, technical data sheets, and analytical test reports.
- Problem-solving, organizational, analytical and critical thinking skills.
- Excellent communication and interpersonal relationship skills and attention to detail.
- Excellent report generation and literature review skills.
- Knowledge of common laboratory chemical analysis techniques (e.g., GCMS, LCMS, ICP, FTIR, XRD/XPS/EDS, SEM, etc), and ability to interpret test methods and generated data.
- Expertise in MS Office and citation management software (e.g. EndNote). Expertise interfacing with database systems (e.g., Access, SQL) is a plus but not required.
- Knowledge of biocompatibility (ISO 10993) or USP Class VI testing is a plus.
- Proven ability to manage confidential information with discretion.
- Knowledge of Environmental Health and Safety and Quality guidelines.
Typical Education / Experience:
Bachelor's Degree in Materials Science, Polymer Chemistry, Chemistry, Chemical Engineering, or related field with 2-4 years of experience required, or Master's Degree in indicated field with 1-2 years of experience required, or PhD in indicated field with 0-1 year of experience required. The candidate should have experience in the medical device or pharmaceutical industry (or relevant university experience).
CO, NY candidates may not be considered.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.