Director of Tissue Product Development
2 weeks ago
At Extremity Care, we are seeking a highly skilled and experienced Director of Tissue Product Development to lead our new product development initiatives. This role will be responsible for driving product strategy, overseeing design and implementation of new products, and ensuring compliance with FDA regulations and industry standards.
Key Responsibilities:- Develop and execute comprehensive strategies for research and new product development in alignment with business objectives.
- Ensure compliance with quality, regulatory, and safety standards, including FDA regulations and AATB standards.
- Establish and maintain engineering and project management procedures, including design control processes.
- Collaborate closely with the regulatory affairs team to develop regulatory strategies for new products.
- Conduct market research to identify new product opportunities and market trends.
- Collaborate with marketing and sales teams on go-to-market strategies for new products.
- Lead and develop project management activities, project schedules, budgets, and deliverables.
- Establish communication channels between project teams and multi-department stakeholders to ensure alignment and efficiencies.
- Oversee the Research & Product Development project timelines, understand critical paths, dependencies, and enforce accountability.
- Support planning and execution of new company initiatives, such as equipment onboarding, and product support.
- Define product goals to guide the design process and refine design concepts based on market feedback.
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
- Participate in risk management activities, including FMEAs, and oversee design reviews to assess project progress and product design.
- Oversee planning and execution of verification and validation activities, ensuring compliance with industry standards and regulations.
- Track and establish product financial metrics, including Gross Margin and COGS, and determine production forecasts post-launch.
- Support the operations team to meet forecasted quantities and improve manufacturing efficiency.
- Author, review, and approve documents related to research and product development, including procedures, protocols, marketing materials, and technical reports.
- Support and oversee execution of validation, verification, and qualification protocols to ensure regulatory compliance.
- Work closely with QA, RA, and other departments to develop quality supplier agreements, labeling, product claims, regulatory strategies, and sales & marketing materials.
- Support the investigation of product quality events and implementation of corrective and preventive actions (CAPA).
- Support the planning and execution of case studies or clinical studies for new products.
- Develop training plans for direct reports on regulatory requirements, design controls, and validations.
- Ensure effective management of laboratory facilities.
- Establish and maintain working relationships with vendors and consultants.
- Oversee the patenting of new technologies and processes, fostering a positive and productive work environment across the Product Development team.
- Conduct performance reviews, monitor annual goals, and establish performance improvement plans as needed.
- Manage direct reports.
- Recruit, interview, and select personnel for hire.
- Attend/participate in offsite business meetings/conferences.
- Travel domestically and internationally up to 15% to attend offsite meetings, conferences, and support business initiatives.
- Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
- Work overtime during weekdays and on the weekend as needed to support business/operational needs.
- Perform other related duties as assigned.
- Bachelor's degree/Master's degree in biomedical engineering, tissue engineering, mechanical engineering from an accredited college or university required.
- 8-10+ years of experience in product development or related field required.
- 5+ years of leadership experience preferred.
- Clearance of favorable background investigation required.
- Experience with 21 CFR 1271 required.
- Experience with 21 CFR Design Controls required.
- Proficiency in project management required.
- Experience with allografts and/or medical devices required.
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