Biologist

With a legacy spanning over 150 years, TUV SUD is a global leader in technical services, employing over 25,000 professionals across 1,000 offices worldwide. For more than 30 years, TUV SUD America has been committed to advancing safety, sustainability, and innovation across 33 locations. Dedicated to protecting people, property, and the environment from technology-related risks, we drive consumer protection, digital transformation, and sustainable development.

TUV SUD's Medical Device Testing Lab located in New Brighton MN, specializes in medical device and packaging testing, offering a comprehensive, one-stop solution for manufacturers. Our lab consists of four specialized disciplines-Biocompatibility, Chemistry, Microbiology, and Packaging-ensuring excellence in medical device evaluation. It is a part of a greater global network of Medical Device testing labs.

Position Summary:

TUV SUD is seeking a knowledgeable biologist who will provide support to the Medical Device Test laboratory team, performing in vitro biocompatibility-based studies/testing, evaluating a variety of medical devices. Laboratory Test Methods include those for Genotoxicity (ISO 10993-3), Hemocompatibility (ISO 10993-4), and Cytotoxicity (ISO 10993-5), along with relevant ASTM, OECD, USP, and JMHLW guidelines. The ideal candidate has a strong laboratory background, as well as excellent project management skills and attention to detail.

Responsibilities:

Perform biocompatibility testing, including but not limited to: C3a Complement Activation Hemocompatibility, Direct Contact Cytotoxicity, MEM Elution Cytotoxicity, MTT Cytotoxicity, NRU Cytotoxicity, PTT, SC5b-9 Complement Activation Hemocompatibility, Mouse Lymphoma Genotoxicity, and Bacterial Reverse Mutation Genotoxicity.

Conduct biocompatibility lab support tasks such as media preparation, sample preparation/extraction of test articles, and customer testing.

Provide scientific support to scientific staff and management in execution, and interpretation of test records to ensure technical integrity of studies.

Ensure adherence to protocol, protocol amendments, and company SOPs throughout the conduct of studies.

Accurately analyze, record, organize, and communicate all data, including unanticipated responses and nonconforming work.

Report clear and concise updates and results to laboratory management.

Work effectively with minimal supervision.

Prioritize and execute daily project tasks and report test results/reports in a timely manner in accordance with expected performance metrics.

Collaborate and clearly communicate with Team Lead, cross-functional teams, to ensure client needs are met.

Maintain and analyze ancillary records (logbooks, worksheets) according to protocols, SOPs, and other regulations.

Lead and support planning and execution of equipment/instrument qualification, validation, and calibration.

Assist Team Leads, Project Managers, Technical Advisors, and other biological team members in establishing test recommendations according to biocompatibility industry guidelines/standards including, but not limited to: ISO 10993, ISO 17025, ISO 13485, GMP, and GLP.

Contribute to continual lab improvements of the laboratory quality system, compliance, and laboratory support.

Provide support and lead in laboratory method development and validation by assisting with creating project timelines, generating new documents, creating document revisions, and providing technical review of documents.

Other duties as assigned by management.

Minimum BS/BA in biology or related scientific field.

Minimum of 4 years of applicable experience in a laboratory environment. Preferred experience with medical device testing for assessment of cytotoxicity, hemocompatibility, and genotoxicity.

Medical device, preclinical, or pharmaceutical laboratory experience.

Knowledge in Study Directing is desired, but not a requirement

Specific Skills, Knowledge and Abilities:

Experience in aseptic technique and work with biological cell lines and/or microorganisms

Experience operating within quality system requirements or regulated environment

Strong problem-solving, analytical and organizational skills

Exhibit excellent written and oral communication skills and be a proactive, collaborative team player

Ability to function independently and within a team environment

Ability to organize and track multiple projects in a detail-oriented and self-directed manner

Self-starter with a positive and motivated attitude

Good working knowledge of industry regulations supporting a medical device environment

Experience with Microsoft Office (Word, Excel, PowerPoint, Teams, Outlook, etc.)

Equal Opportunity Employer - Disability and Veteran

TUV SUD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following:

TUV SUD Recruiting