Russell Solutions Group
Location
Menlo Park, CA | United States
Job 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.
RESPONSIBILITIES:
•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.
REQUIREMENTS:
•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
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