Manufacturing Engineer

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 Manufacturing engineer to join the team and lead these activities through clinical trials and toward commercialization.

Part-time optional. 

Responsibilities

o  Coordinate vendors and subcontractors to ensure timely and efficient delivery of production requirements.

o  Participate in hands-on manufacturing processes, troubleshooting, and optimizing workflows. Develop work instructions and production processes.

o  Collaborate with internal and external teams (subcontractors) to address production challenges and maintain high-quality standards.

o  Ensure adherence to project timelines and budgets while meeting production objectives and clinical study demands.

o  Work closely with QA and RA teams to ensure products meet all regulatory and quality standards.

o  Work closely with the clinical teams to allow improve and drive product development. Support and troubleshoot the clinical team during cases.

o  Develop and maintain manufacturing jigs, ensuring efficiency and consistency in production processes.

o  Oversee and participate in process validation to confirm manufacturing procedures meet required standards.

Ensure design assurance by collaborating with the engineering team to validate and verify design specifications align with production capabilities

Education & Experience

• BSc in Engineering.
• 5-15 years of experience in medical device R&D and manufacturing.
• In-depth knowledge of regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Experience with hands-on development of catheter-based cardiovascular products
• Experience in coatings processes, materials, and quality control
• Experience with FDA regulatory submissions
• Experience working in a multinational company – advantage
• Experience with the commercialization of medical device products - advantage

Skills & Competencies

·       Independent, a team player, and hands-on.

• Excellent problem-solving, decision-making, and project management skills.
• Expertise in product development lifecycles and production scale-up processes including process validation.
• Knowledge of catheter manufacturing techniques

Location: Netanya