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Scientist I

Overview:

Tympanogen is a medical device company based in Richmond, VA that is on a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry, and are transforming eardrum surgery into an office-based procedure. We are hiring a Scientist I to support our team through the rigorous application of scientific principles to experiment design and execution in a device research laboratory. This position works with research and development team members to implement and maintain successful product development and quality control practices. The duties for the Scientist I would include:

  • Assisting with reagent production
  • Preparing and characterizing gel-based devices using SOPs
  • Quality testing device components and developing protocols
  • Operating equipment such as analytical balance, centrifuge, pH meter, stir plates, rheometer etc.
  • Executing techniques to characterize synthesized reagents
  • Assisting with data collection and analysis
  • Maintaining records and documenting activities in electronic lab notebook
  • Utilizing project management software to manage and track activities
  • Preparing reports and presentations of results obtained through experiments
  • Shipping samples to contractors

Ideal Qualifications:

  • Bachelor’s degree in chemistry, biochemistry, chemical engineering, biomedical engineering, biology, or related field
  • At least one year of previous lab experience
  • A basic knowledge of Microsoft-based computer programs including some scientific, graphic, and statistical software is required.

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Clinical Affairs Manager

Overview:

Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and transform eardrum surgery into an office-based procedure. We are seeking an experienced Clinical Affairs Manager to lead a clinical study for one of our devices, and to support future clinical plans. This position reports to the CEO and works closely with our regulatory team to ensure the study runs effectively. An ambitious candidate with a track record of successful clinical study operations would thrive in this role. The duties for the Clinical Affairs Manager include:


Develop, plan, implement, and manage clinical study activities, including:

  • Project planning and clinical study design development
  • Collaboration with Leadership, Regulatory, and other functional groups or key stakeholders to establish and implement plans consistent with business objectives
  • Establish clinical study plans, timelines, and resourcing needs
  • Manage resources (internal/external) to successfully execute clinical trials within budget and schedules
  • Oversee development of core clinical documents including clinical study protocol, case report forms (CRFs), informed consent forms, and clinical study agreements
  • Participate in study site selection including ensuring appropriate qualification of investigational sites for clinical trials
  • Develop and manage study budgets efficiently with study sites
  • Negotiate clinical trial contracts with clinical study sites


Interface with Leadership, Regulatory and other functional teams or partners to provide project status reports and to ensure study plans are implemented and executed in compliance with applicable regulations, quality systems or procedure requirements, and in alignment with business objectives


Oversee all clinical study operational aspects to ensure clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures including:

  • Ensures appropriate preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval. Ensures maintenance of approval throughout the duration of the study and ensures compliance to IRB reporting requirements and with national and international regulations.
  • Helps to ensure appropriate training is provided to clinical investigators and staff regarding data collection and reporting requirements as necessary.
  • Oversees data management system, including selection, development and implementation of systems to ensure the proper recording, collection, verification, validation, processing, analysis and storage of information collected in a clinical Study.
  • Oversees operation to ensure all necessary documentation, including contract agreements are executed, signed and archived.
  • Provides status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, and Investigators.
  • Act as a liaison to study sites and assist or support study sites with trial execution. Activities may include site qualification visits, site initiation visits and training, monitoring visits to review the study data and verify the accuracy of the data against the site’s medical records, and site close-out visit.
  • Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to: input related to FDA submission questions, literature reviews, and development of Clinical Evaluation Reports (CERs) for design dossiers.


Knowledge and Skill Requirements:

  • Working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB procedures governing the conduct of human clinical research
  • Accuracy, reliability, and high level of attention to detail
  • Strong level of professionalism, including verbal and written skills
  • Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
  • Familiarity with medical and anatomical terminology
  • Demonstrated ability to manage projects
  • Excellent organizational and interpersonal skills
  • Strong verbal and written communication skills
  • Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint

Preferred Qualifications:

  • Bachelors degree in a relevant scientific discipline or related field
  • Minimum 5 years of clinical study experience
  • Ability to travel 20% for site visits

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Director Of Product Development

Overview:  

Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and transform eardrum surgery into an office-based procedure. We are hiring a Director of Product Development to accelerate our first product to market. This senior position reports to the CEO and works closely with multifunctional team members to guide and execute timelines to drive the product through development, regulatory approval, and product launch. An ambitious candidate with a track record of successful medical device development who wants to lead a new department in a fast-growing startup would thrive in this role. The duties for the Director of Product Development include:  

  • Plan, lead, and drive the execution of the product development plan for a de novo, Class II device;
  • Provide vision and process expertise to align cross-functional teams on early-stage ideas through commercial launch of ENT devices;
  • Lead relationships with contractors and vendors in supply chain;
  • Lead development of a product portfolio strategy that is aligned with Company goals;
  • Align product development activities and goals with industry-standard quality management system practices and regulatory compliance requirements;
  • Lead technical project leaders to ensure product development timeline execution;
  • Utilize Company’s project management platform to track and report project progress and timelines;
  • Evaluate product risk according to industry standards;
  • Manage team expansion and expense budgets that prioritize spending for commercial execution;
  • Communicate regularly with senior leadership about ongoing operations and project progress;
  • Present product development plans, budgets, and strategic initiatives to senior leadership;
  • Mentor team members on how to execute a product development plan and align product development goals with FDA expectations.  

Preferred Qualifications: 

  • Bachelor’s degree in engineering discipline;
  • Minimum 7 years of product development experience in the medical device industry;
  • Minimum 5 years of managerial experience;
  • Proven budget management experience;
  • Experience developing medical devices under ISO 13485 standards;
  • Experience with Netsuite preferred;
  • Mentorship experience guiding junior employees;
  • Strong oral and written communication skills and interpersonal skills;
  • High degree of initiative and self-motivation;
  • Ability to travel to vendor sites as needed – 10-20% time.
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Special notes

Apply for Your Next Career

We are always interested in talking to talented people.  If you have done amazing work in your career you’d like to share, send us your resume and examples of your work. You can either submit a form on one of the job postings above or you can email your information to info@tympanogen.com. We look forward to hearing from you!

COVID Vaccination Requirement:

In order to safeguard the health and safety of our employees, customers, and broader community, Tympanogen requires that all employees be fully vaccinated* prior to beginning employment. This policy is a condition of employment and requires proof of vaccination(s).

*Fully vaccinated as defined by the CDC and employees must remain fully vaccinated during employment. Other vaccinations may be required for the position to satisfy credentialing requirements at hospitals.