Sr. R&D Engineer
About The Position
Route 92 Medical is seeking a Sr. R&D Engineer to use engineering expertise to design and develop innovative medical devices, components, and subsystems in support of the company’s strategic objectives. The role contributes to product development and enhancement from early concepts through commercialization, while supporting product quality, regulatory compliance, and patient safety. The position works across engineering and other functions to solve product and system-level problems, develop and test designs, prepare technical documentation, support pilot production, and provide engineering support for products and physician in-service programs. The engineer also helps maintain the company’s intellectual property, oversees vendors and consultants as needed, and supports the investigation and resolution of product complaints and safety issues.
Requirements
- Bachelor’s degree in Engineering required; Mechanical or Biomedical Engineering preferred.
- Minimum of 5 years of experience in an Engineering role in the medical device industry.
- Working knowledge of computer-aided design (CAD) tools.
- Strong engineering problem-solving skills 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 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.
- Ability to travel up to 15%.
Nice To Haves
- Mechanical or Biomedical Engineering degree preferred.
- SolidWorks experience preferred.
- Experience with catheter-based products preferred.
Responsibilities
- Develop and prototype new product designs and product enhancements based on user needs.
- Participate on cross-functional teams managing 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.
Benefits
- Comprehensive healthcare benefits effective on day one, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term Disability, Critical Illness Insurance, and Accident Insurance.
- Competitive base pay plus corporate bonus program.
- Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July.
- 12 weeks of paid parental leave after 90 days of employment.
- Monthly cell phone stipend.
- Role may also be eligible for equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
