Overview:
The Director of R&D is responsible for the day-to-day management of the R&D Department. In this role, you will establish consistent program management practices and procedures, communicate these throughout the organization, and ensure operational excellence in their execution. This position requires equal parts team leadership, cross-functional strategic planning, and hands-on execution. This role reports to the Chief Technology Officer.
Duties and Responsibilities:
Leadership and Planning:
- Collaborate with senior management to define the product development strategy, including software, hardware and instrumentation.
- Work closely with leadership from R&D and Product Marketing to identify key projects and establish development roadmaps.
- Collaborate with other departments, including Marketing, Sales, Customer Support and Operations, to ensure a holistic approach to product development and delivery.
- Align product development roadmaps with the company’s overall business goals.
- Regularly report on progress and areas for improvement to senior management.
Product Development:
- Drive the entire product development lifecycle, from ideation to launch, through all design control phases, including planning, development, verification/validation and transfer to Operations.
- Work with senior management to define product requirements and ensure they align with market demands and customer needs.
- Ensure compliance of product development activities and associated documentation with regulatory requirements, quality standards, and relevant industry guidelines (FDA, ISO, etc.).
- Lead the development and testing of hardware and software prototypes, including electrical safety tests, usability evaluations and cadaver tests.
- Actively participate in hands-on activities such as design reviews, risk assessments, technical troubleshooting, and problem-solving.
- Take a lead role in documentation processes, ensuring that accurate and comprehensive records are maintained throughout the R&D lifecycle.
- Work closely with the team as well as Regulatory/Quality Affairs to document design specifications, test protocols, and regulatory submissions.
Software Engineering:
- Oversee software architecture, design, development and testing, ensuring patient safety, reliability, and security.
- Implement best practices, methodologies, and technologies to improve software development processes.
Resource Management:
- Build and manage multi-disciplinary project teams
- Manage budgets, resource allocation, and project timelines.
- Collaborate with HR to recruit, train, and retain top software engineering and product development talent.
- Mentor and develop engineering team members.
- Identify and engage external consultants, subject matter experts, or specialized firms to supplement R&D capabilities or provide niche expertise and ensure effective management of their involvement.
- Collaborate with test labs to define testing protocols, ensure compliance with regulatory standards, and oversee the timely and accurate execution of tests.
- In collaboration with Operations and Quality Assurance, identify, evaluate and select suitable suppliers for delivering product components or materials required for R&D projects.
Required Skills and Qualifications:
- Bachelor’s or Master’s degree in biomedical engineering or a related technical field.
- Proven experience in medical device engineering and product development, with a strong track record of successful product launches.
- Prior leadership experience in managing medical device product development teams.
- Experience with 510(k) clearances and medical devices.
- Understanding of software development methodologies, technologies, and trends, including Agile life cycle in the context of medical devices.
- Strong problem-solving and decision-making abilities.
- Relevant industry certifications.
- Successful track record working with cross-functional development teams
- Strong leadership, communication and writing skills with the ability to author detailed reports and documentation as well as to synthesize technical information and present it to specialists and non-specialists.
This position will be based in Bedford, MA.
Contact: