Sr RD Engineer

Russell Solutions Group; South San Francisco (CA); On-site; USD 140,000 - 195,000; Full time

Job summary

Russell Solutions Group, a venture-backed medical device startup in California, is seeking a Senior R&D Engineer to lead design, development, and manufacturability of new devices. You will collaborate with cross-functional teams and external stakeholders to translate customer needs into robust products.

Responsibilities include concept-to-market product development, design control compliance, risk mitigation, test fixture creation, and documentation.

Qualifications

• Minimum 5 years of medical device R&D experience.
• Experience with design controls and development procedures.
• Excellent problem-solving and collaboration abilities.
• Strong written and verbal communication.

Responsibilities

• Design and develop new products from concept to market release.
• Develop methodologies and processes to support product development and transfer to manufacturing.
• Participate in idea generation and IP development.
• Maintain design history and ensure regulatory readiness.
• Support manufacturing transitions and tooling as required.

Skills

Strong communication

Documentation

Data-driven decisions

Startup multitasking

Education

Bachelor's degree in Engineering or equivalent

Tools

SolidWorks

Microsoft Office

Job description

A venture capital-backed medical device company is hiring a Sr. R&D Engineer who will be responsible for the design, development, and manufacturability of products, ensuring that products are designed to meet customer and manufacturability requirements. Interact with other disciplines within the company to ensure appropriate process development and feedback. Direct interface with suppliers as well as customers (physicians) may be required. This is an excellent opportunity to join a growing startup company at an exciting time in its development.

Requirements

MAJOR DUTIES AND RESPONSIBILITIES

• Design and develop new products from concept to market release that address market and customer needs.
• Design and implement new methodologies, materials, and processes to support product development and transfer to manufacturing.
• Actively participate and contribute to idea generation such as through brainstorming and IP development.
• Use data-based recommendations when contributing to design change decisions.
• Design and build test and assembly fixtures for both product development and manufacturing.
• Ensure design control requirements are met, manage product development timelines and work with a cross functional team to bring new devices to commercialization in a timely fashion.
• Work within aggressive timelines to manage product development projects. Timely communication of project progress and issues to management.
• Test designs to validate the ability to function as intended and offer design modifications to meet specific market needs.
• Perform verification testing to establish that new devices meet design input specifications.
• Conduct feasibility studies throughout the development process to ensure desired functionality and vet possible enhancements (this includes planning of outside animal and cadaver studies).
• Develop tools, if required, to accompany marketed device.
• Create detailed documentation throughout the various stages and steps in research and development.
• Work closely with manufacturing to ensure smooth transitions to commercial production.
• Assume other projects/assignments as assigned.
• May be required to provide technical support for regulatory, clinical or sales efforts.
• Document invention disclosures to contribute to intellectual property portfolio.

Preferred Qualifications

Education and/or Job Experience

• Bachelor's degree in Engineering or equivalent.
• At least 5 years of medical device R&D experience.

Skills, Abilities, and Requirements

• Proficiency in SolidWorks for solid models and dimensioned drawings.
• Good communication and documentation skills.
• Strong computer skills and electronic data capture experience.
• Ability to multi-task and prioritize with flexibility required in a start-up environment.
• Proficient in Microsoft Word/Excel/PowerPoint.