REQUIRED QUALIFICATIONS

• Bachelor’s Degree in Engineering (Electrical, Biomedical preferred)
• 4+ years of related working experience from a regulated manufacturing industry
• 3+ years of relevant design control experience
• Experience with the overall design and development process

PREFERRED QUALIFICATIONS

• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
• Self-starter with the ability to quickly learn about new processes
• Excellent analytical and communication skills (both written and oral)
• Able to work independently and in a multidisciplinary team environment

ABOUT THE ROLE

The R&D Engineer III will join our Access Solutions Site to lead the development of our next generation steerable sheath for the franchise. This role will develop new technology, products, equipment, and processes with minimal supervision. Furthermore, they will compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Support complex cutting-edge medical device systems through prototyping, testing and modeling.
• Develop device design history files (i.e., requirements, risk management, usability files.
• Ensure compliance to industry and international standards.
• Develop verification and validation plans, protocols, and reports.
• Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
• Conduct work across the full scope of technical and documentation activities for the department.
• Make independent studies, analyses, interpretations, and conclusions.
• Responsible for technical input into project level planning.
• Provide technical guidance to review work plans and advise on unusual features of projects
• Provide technical, project level leadership to engineering assistants or junior engineering staff.
• Participate in failure investigations and repair planning.
• Assist in DFM (Design for Manufacturing) activities.
• Develop and test new manufacturing processes.
• Support regulatory filings to various government bodies as required.
• Support the development of intellectual property where required.
• Support pre-clinical and clinical research activities where required.
• Other duties as required.