Sr. R&D Engineer

Purpose of Job

Use engineering expertise to design and develop innovative medical devices, components, and subsystems in support of Route 92 Medical's strategic objectives. This role contributes to product development and enhancement activities from early concepts through commercialization while supporting product quality, regulatory compliance, and patient safety.

Responsibilities

• Develop and prototype new product designs and product enhancements based on user needs.
• Participate on cross-functional teams that manage projects from concept through commercialization.
• Solve engineering problems at the component, subsystem, and system levels.
• Conduct testing using established protocols and methods, and develop new test methods as needed.
• Develop protocols and reports and perform verification and validation testing.
• Prepare document change requests (DCRs) and coordinate implementation of approved changes.
• Direct work performed by technicians and temporary workers, as needed.
• Complete projects, including product enhancements, in alignment with corporate objectives.
• Contribute to the company's intellectual property position through inventions and patent applications.
• Maintain accurate documentation of concepts, designs, drawings, test results, and processes.
• Maintain current knowledge of competitive technologies and relevant medical, technical, and biomedical developments.
• Provide engineering and technical support for products and physician in-service programs.
• Oversee outside vendors and consultants, as required.
• Provide engineering support for the investigation and resolution of product complaints and safety issues.
• Partner with Engineering, Manufacturing, Clinical Affairs, Sales and Marketing, and Quality Assurance to coordinate pilot production of new products.
• Support company goals, policies, and procedures and comply with applicable Quality System Regulation (QSR) and FDA requirements.

Skills for Success

• Working knowledge of computer-aided design (CAD) tools, preferably SolidWorks.
• Strong engineering problem-solving skills with the ability to work at the component, subsystem, and system levels.
• Ability to develop clear technical documentation, including protocols, reports, drawings, and change documentation.
• Effective written and verbal communication skills and the ability to collaborate across functions.
• Ability to work independently and contribute effectively in a team environment.
• Proficiency with word processing and basic spreadsheet applications.
• Ability to manage multiple priorities in a product development environment while maintaining attention to quality and compliance.
• Experience with catheter-based products is preferred.
• Ability to travel up to 15%

Required Education

Bachelor's degree in Engineering required; preferred Mechanical or Biomedical Engineering.

Required Experience

Minimum of 5 years of experience in an Engineering role in the medical device industry.