Sr RD Engineer - Menlo Park, United States - Russell Solutions Group

Description

We are looking for a versatile, hands-on Senior/ Principal R&D Engineer to join a passionate team and drive this technology forward.

The primary responsibilities will be the development of the implant and support the development of the delivery system and overall therapy.

• Incorporate user needs for the development of a robust pulmonary implant.
• Establish understanding of disease state and historic and current technologies.
• Establish/review Product Specifications for the Apreo implant and/or overall system.
• Design test methods for implant and/or delivery system.
• Develop specifications and justifications for testing.
• Adhere to the Company's Design Control and QMS for the design and development.
• Manage and mentor technicians as required.
• Provide project updates during team meetings as required.
• Work cohesively with the entire product development team (R&D, MFG, RA, QA, CA).
• Work with the manufacturing engineer to ensure efficient transfer.
• Draft test protocols, execute testing, analyze data, and write test reports.
• Generate Intellectual Property and advance the Company's IP position.
• Participate in labs with team members and/or physicians.
• Provide technical support/training to team members and/or physicians.

• BS in Mechanical Engineering, Material Engineering, Biomedical Engineering or related discipline or equivalent experience.
• Experience in start-up environment preferred.
• 5+ years in medical device R&D
• Experience with implantable and/or delivery system product development
• Experience working in compliance with Quality Systems designed to meet regulatory requirements, such as, but not limited to FDA, QSR, ISO13485, MDD/MDR, etc.
• Experience with MS Project or other planning tools preferred
• Experience in start-up and scale-up of new product introductions
• Strong knowledge of analytical tools and CAD software (i.e. SolidWorks)
• Strong knowledge of mechanical design, component design, material selection
• Working knowledge of machine shop equipment (i.e. mills, lathes)
• Excellent communication skills (both written and verbal) required
• Ability to work independently and in a team setting required
• Must be able to travel domestically and internationally periodically