Sr. R&D Engineer

Route 92 Medical Inc; Hayward Park (CA); On-site; USD 140,000 - 160,000; Full time

Benefits offered by this job

Healthcare benefits

Paid time off

Parental leave

Cell phone stipend

Job summary

Route 92 Medical Inc. in San Mateo, CA, seeks a Full-Time R&D Engineer to design and develop innovative medical devices from concept to commercialization.

You will collaborate across teams to ensure quality, regulatory compliance, and patient safety, contributing to product improvements and IP strategy. Applicants should have a mechanical or biomedical engineering background, 5+ years in medical devices, CAD proficiency (SolidWorks), and the ability to travel up to 15% as needed.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum of 5 years engineering experience in medical devices.
• Knowledge of QSR and FDA requirements.
• Strong CAD proficiency and documentation skills.

Responsibilities

• Develop and prototype new product designs and enhancements.
• Lead cross-functional teams from concept to commercialization.
• Solve engineering problems at component, subsystem, and system levels.
• Develop test protocols and validate results.
• Prepare change documents and coordinate implementation.

Skills

CAD

Engineering problem-solving

Technical documentation

Communication skills

Team collaboration

Microsoft Office

Project management

Catheter-based products

Willing to travel

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Job description

Research & Development FullTime Professional San Mateo, CA, US

Salary Range: $140,000.00 To $160,000.00 Annually

About Route 92 Medical

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.

We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.

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.

BENEFITS & PERKS

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term Disability, Critical Illness Insurance, and Accident Insurance.
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July.
• 12 weeks of paid parental leave for employees after 90 days of employment.
• Monthly cell phone stipend.

The actual base pay is dependent on several factors, including, but not limited to, work experience, market data, skills, geographic location, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity.