Director of Product Development
Tympanogen
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.
Key Responsibilities
- 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.
Experience and Qualifications
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.
Sector
Job Type
Benefits
- Medical insurance
- Dental insurance
- 401k