Study Director

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 Study Director who will provide support to the Medical Device Test laboratory team, effectively study directing and performing microbiology and biocompatibility-based studies/testing, evaluating a variety of medical devices. Laboratory Test Methods include those for sterility assurance (i.e., bioburden, sterility, endotoxin testing, biological indicators) and Cleaning, Disinfection, and Sterilization Validation Studies for Reusable Devices, as well as cytotoxicity, genotoxicity, and hemocompatibility according to ISO 10993, ASTM, OECD, USP, and JMHLW guidelines. The ideal candidate has a strong and exhaustive laboratory background, as well as excellent project management skills and attention to detail.

Responsibilities:

Performs Study Director functions as outlined by FDA Good Laboratory Practices (21 CFR Part 58) for GLP Studies, as well as serves as an in-laboratory Microbiologist and Biologist ensuring proper execution of both microbiology and biocompatibility testing, including but not limited to the following assays: reusable device testing, bioburden, sterility, endotoxin, biological indicators, 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.

Provides scientific support and guidance to scientific staff and clients in the study design, conduct, and interpretation of test records to ensure technical integrity of studies.

Generates protocols, protocol amendments, custom test records, non-conforming work, and reports in adherence to GLP and/or test method regulations.

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

Assures that all data including unanticipated responses and nonconforming work are accurately analyzed, recorded, organized, and communicated clearly to the client.

Utilize strong project management skills to efficiently manage multiple studies.

When performing testing, adheres to protocol, protocol amendments, and company SOPs throughout the conduct of studies.

Performing microbiology and biocompatibility lab support needs not limited to media preparation, sample preparation/extraction of test articles, instrument calibrations, microbial testing, and customer testing.

Reports clear and concise updates and results to laboratory management.

Ability to work and be effective with minimal supervision.

Ability to prioritize and execute on 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, and clients to ensure client's needs are met.

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

Provides guidance regarding testing/study execution to laboratory analysts and the laboratory support team, including scientific project managers, test facility management, laboratory coordinators, and the quality assurance unit.

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

Assists Team Leads, Project Managers, Technical Advisors, and other biological team members in establishing test recommendations according to microbiology and biocompatibility industry guidelines/standards including, but not limited to: ISO 11135, ANSI/AAMI ST72, USP <85>, USP <161>, ISO 11737-1, USP <61>, USP<71>, ISO 11737-2, ISO 17664-1, ISO 17664-2, ANSI/AAMI/ISO 17665, ANSI/AAMI ST98, ANSI/AAMI ST79, ANSI/AAMI TIR 12, ASTM F3438, ISO 11737-3, ANSI/AAMI ST72, ISO 10993, ISO 17025, ISO 13485, GMP, 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.

Education and Experience:

Minimum BS/BA in microbiology or biology related field

Minimum of 4 years applicable of experience in a laboratory environment. Preferred experience with medical device reprocessing validations, sterility testing, sterilization (EO, Steam, Dry Heat, Gamma), bioburden, and endotoxin testing

At least one year as a study director in the medical device industry

Medical device or pharmaceutical laboratory/sterilization experience

Specific Skills, Knowledge and Abilities:

Experience in aseptic technique and work with 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.)

Fundamental competencies form the foundation for individual and organizational success in TUV SUD and apply to all employees and showcase behaviors aligned to TUV SUD values and culture cornerstones and will be evaluated in performance assessments.:

Communication

Collaboration

Customer Orientation

Self Management

This full-time position's anticipated annual base pay range is $70,000-$80,000. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target, subject to eligibility and other requirements. Additionally, we offer a comprehensive benefits package to employees, including a 401(k) plan with employer match, 12 weeks of paid parental leave, health plans (medical, dental, and vision), life insurance and disability, and generous paid time off.

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