Job Title: R&D Engineer

Job Description

We are seeking a skilled R&D Engineer to join our dynamic engineering team. You will play a crucial role in extending the shelf life of our product and addressing manufacturing requirements. Your expertise will contribute to the successful commercialization of our innovative medical device as we expand our operations.

Responsibilities

• Assist the engineering team in extending the shelf life of products, particularly catheters.
• Participate in shelf-life testing and redefine or remediate product requirements to meet clinical needs and standards.
• Conduct design verification and validation processes, ensuring product quality and compliance.
• Utilize Solidworks to design connectors for multiple catheters.
• Perform DOEs testing and operate the Instron pull test machine.

Essential Skills

• Medical device experience
• Shelf life testing expertise
• Proficiency in product requirements definition and remediation
• Knowledge of design verification and validation processes
• Solidworks proficiency
• Experience with DOEs testing and Instron pull test machine

Additional Skills & Qualifications

• 5-7 years of relevant experience
• Injection molding experience
• Experience in 1-2 product cycles
• Understanding of product interaction with end clients

Work Environment

Join a growing startup with a team size of approximately 80-100 people. We recently received FDA 510(k) clearance and are entering the commercialization phase, expanding into a second building to enhance our R&D and manufacturing capabilities.