Principal R&D Catheter Engineer, Shifamed

at  Shifamed

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

DESCRIPTION

This position represents an exciting opportunity to join the Shifamed new projects team. We are currently looking for a hands-on catheter engineer who is a creative thinker, problem-solver, collaborative team player and active in their approach to concept generation and execution. This is a full-time on-site position and will require reporting to our offices located in Campbell, CA.

EDUCATION & WORK EXPERIENCE

• B.S. degree in Material Science Mechanical Engineering, Biomedical Engineering or related Science. An advanced degree (M.S. or Ph.D.) in any of these fields is preferred.
• 12+ years’ work experience, in the medical device industry preferred.
  Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.
  NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com

• Lead development of innovative and novel medical technologies to solve clinical problems from feasibility prototypes through clinical use.
• Hands-on prototyping and development of device, processes, and testing.
• Work as part of a cross-functional team to develop and evaluate product designs through verification and validation testing.
• Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions.
• Provide periodic updates regarding project status.
• Contribute to the company’s intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice.
• Interact with physicians regarding product development, testing, and product demonstrations.
• Proficient in design and development of medical devices, primarily in catheter or flexible instrument design and development.
• Extensive knowledge and proven track record of flexible instrument design and development of commercially available products.
• Proficient in CAD design and documentation software; SolidWorks preferred.
• Experience with Nitinol processing, laser cutting, and injection molding a plus.
• Experience in developing test methods; designing and making test and process fixtures and equipment.
• Basic machine shop skills.
• Demonstrated ability of working with suppliers, including understanding of capabilities, materials, and fabrication processes.
• Knowledgeable about medical device regulations.
• Experience working in a lab and CER.
• Excellent communication skills; ability to work both independently and in project team setting.
• Previous startup-experience is a preferred.