Boston Scientific Scientist III 

United States, Minnesota, Arden Hills 

500073713

Your Responsibilities Will Include:

• Perform trace metals analysis using established instrumentation settings, processing, and reporting methods.
• Develop new trace metal test methods for quality control and investigational testing using ICP/OES or ICP/MS.
• Perform routine laboratory testing in accordance with FDA and other regulatory requirements, and internally established procedures.
• Assure the quality of medical device and combination products by supporting material and finished goods release testing.
• Proactive communication and coordination of material and finished goods release testing to ensure work is completed on required customer timelines.
• Escalate laboratory resourcing and testing capabilities constraints with laboratory management and customers.
• Partner with external laboratories to ensure material and finished good testing is completed per Boston Scientific’s quality and business requirements.
• Lead equipment qualifications, software validation, method validations, and method transfer activities.
• Support documentation and investigation for out of specifications, atypical results, and laboratory deviations.
• Support technical writing and ownership of laboratory procedures, work instructions, and test methods.
• Support internal and external regulatory audits.
• Drive continuous improvement, optimization, and other special projects for the laboratory.

Required Qualifications:

• Minimum of a BS degree in Chemistry, Biology, or related degree
• Minimum of 2-4 years of technical experience in laboratory setting with basic skills such as pipetting, good weighing practices, utilization of class A glassware, solution and standard preparations, and handling of chemicals.
• Minimum of 4 years of industry experience operating trace metals equipment such as ICP/OES or ICP/MS.
• Working knowledge of cGMP, 21 CFR Part 11, and/or ISO 17025. Ability to understand other medical device and combination product regulations and standards.
• Previous validation experience (analytical test equipment, test method, and/or software).
• Previous experience as laboratory coordinator/project manager.

Preferred Qualifications:

• Minimum of 5 years of technical experience in laboratory setting with basic skills such as pipetting, good weighing practices, utilization of class A glassware, solution and standard preparations, and handling of chemicals.
• Strong communication, presentation, facilitation, and project management skills.
• Ability to work with a diverse team and contributes to an inclusive work environment

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.