R&D Director

Job Description: R&D Director

Revamp Medical is a VC-backed medical device start-up, developing novel treatment for Acute Heart Failure patients. Currently in clinical trials both FDA and EU, with extensive R&D activities. We are looking for a passionate R&D Director to join the team and lead these activities towards through clinical trials and towards commercialization.

Responsibilities

Research & Development (R&D)

• Lead the development and execution of R&D projects, from concept to implementation.
• Develop and maintain detailed technical documentation, including design specifications and protocols.
• Collaborate with IP team to identify and protect intellectual property.
• Develop parts and processes to allow scale-up towards commercialization
• Tutor R&D team
  

• Plan and design products that are robust, reproducible, and capable of withstanding Verification and Validation (V&V) processes.
• Plan, manage, and execute oversee V&V activities to ensure products meet design and regulatory requirements for pivotal study and future PMA submission.
• Identify and resolve technical and design issues uncovered during V&V activities.
  

• Work closely with QA and RA teams to ensure products meet all regulatory and quality standards.
• Work closely with the clinical teams to allow improve and drive product development. Support and troubleshoot the clinical team during cases.
• Prepare and maintain documentation required for regulatory submissions and audits.
• Drive a culture of compliance, risk management, and continuous improvement across R&D and production.
  

• BSc in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 7-10 years of experience in medical device R&D and manufacturing, with at least 3 years in a leadership role.
• In-depth knowledge of regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR). - advantage
• Experience with hands-on development of catheter-based cardiovascular products
• Experience with FDA regulatory submissions
• Experience working in a multinational company – advantage
• Experience with commercialization of medical device products – advantage
  

• Independent, a team player, and hands-on.
• Strong leadership and team management capabilities.
• Excellent problem-solving, decision-making, and project management skills.
• Expertise in product development lifecycles and production scale-up processes.
• Knowledge of catheter manufacturing techniques