Design Verification Engineer

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 a Design Verification Engineer to join our high-performing medical device development team. Under management direction, the Development Verification Engineer will contribute directly to the development of novel medical devices from feasibility design and prototyping through design validation testing and regulatory submission. The Design Verification Engineer will work with a cross-functional team to support initial design & 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. 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 design verification and validation
• Perform mechanical design activities to assist in test methods and manufacturing fixtures and equipment
• Technical writing in support of test methods, manufacturing methods, test protocols and test reports
• Ability to plan and execute process qualification and validation activities
• Manufacturing line layout and manufacturing instruction generation
• Strong team interactions to meet project timelines
• Collaborate with internal and external partners e.g. external test houses, laboratories, contract manufacturers, quality, and device design engineers
• Managing of technicians and engineers relating to project deliverables
• Prioritize work effectively, managing multiple project goals
• 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:

• Bachelor's degree in engineering (Mechanical, Bioengineering, Biomedical, or related discipline).
• 4 to 7 years of experience in medical device development, with a primary focus on product design verification and validation (V&V) activities
• Working knowledge of design validation principles, including user needs, intended use, and simulated-use or use-case testing.
• Experience owning and driving product builds for verification and validation, including: build planning and documentation