About Evolve:
Evolve Medtech Partners is a medical device development company and incubator. We partner with companies, inventors, physicians, and investors to quickly and efficiently bring ideas from invention to reality within a regulated environment. We launch and support early-stage medical device ventures from our facility in Solana Beach, CA, where start-ups are co-located and guided by our experienced team and network of entrepreneurs. Our team provides leadership and know-how at all stages of product and commercial development, leveraging our vast experience and past successes to rapidly innovate and develop medical devices. Our team and extended network have expertise in product development, intellectual property strategy, regulatory affairs, quality systems, manufacturing, commercialization, clinical, and business development fields.
About the Role:
Evolve is looking for an R&D Engineer to join our high-performing medical device development team. Under management direction, the R&D Engineer will contribute directly to the development of novel medical devices from feasibility design and prototyping through design validation testing and regulatory submission. The R&D Engineer will work with a cross-functional team to support initial manufacturing through process development and process validation. This position offers the opportunity to contribute to the full product development cycle, while ensuring compliance with Evolve’s Quality System and design control procedures. This role is 100% in-person in Solana Beach. Compensation will depend on experience.
Essential Responsibilities/Functions:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily:
- Contribute to the design and development of medical devices from feasibility prototypes through production
- Apply critical thinking and engineering principles to evaluate and identify solutions
- Work collaboratively with the project teams to meet project timelines
- Prioritize work effectively, managing multiple project goals
- Own and drive completion of engineering sub-projects with limited supervision
- Create product design documentation including technical drawings and specifications
- Develop and execute test methods and protocols, oversee and train technicians, analyze data, and author test reports
- Collaborate with internal and external partners e.g. laboratories, manufactures, packagers, and clinical professionals, to verify that medical devices meet applicable regulatory and performance requirements
- Perform fabrication of prototypes, fixtures, and test equipment using a variety of rapid prototyping and/or commercial manufacturing techniques
- Understand Design for Manufacturing (DFM) principles, and support design transfer into manufacturing
- Ensure compliance with Evolve’s Quality Management System (QMS)
- Evolve Medtech Partners is a startup entrepreneurial environment, and each employee may be asked to assist in work areas outside of their usual duties.
- Occasional travel up to 10%
- Ability to commute daily to Solana Beach, CA
Required Qualifications:
- BS in engineering (mechanical or biomedical preferred)
- 3 to 7 years of related work experience in the medical device field or related industry
- Proficiency in Solidworks
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, and Outlook)
- Excellent verbal and written communication skills
- Strong teamwork skills and demonstrated ability to work closely with cross functional partners
- Ability to work in a fast-paced environment on multiple projects simultaneously
Desired Qualifications:
- Experience supporting regulatory submission of medical devices
- Understanding of relevant materials, components, and manufacturing processes for medical devices
- Strong understanding of data analysis and statistics for medical device development and manufacturing
- Understanding of FDA 21 CFR 820 requirements, ISO 13485, and other applicable international standards
- Commitment to company with ability to function within a start-up environment
Job Type: Full-time
Benefits:
- 401(k)
- Health insurance
- Paid time off
Experience:
- Mechanical/Bio Engineering: 3 years (Preferred)
Work Location: In person
