Job Title: Senior R&D Engineer - Shelf-life Testing

Job Description

As a Senior R&D Engineer, you will play a crucial role in assisting the engineering team with enhancing the shelf life of products and meeting manufacturing requirements. You will be involved in product cycles, understanding product interactions with end clients, and ensuring compliance with industry standards.

Responsibilities

• Extend the shelf life for products, particularly catheters.
• Redefine or remediate product requirements to align with clinical needs and standards.
• Conduct shelf-life testing, with a preference for catheter shelf-life testing.
• Participate in design verification and validation processes.
• Utilize Instron pull test machines for testing.
• Conduct Design of Experiments (DOEs) testing.
• Use SolidWorks to design couplers for connecting multiple catheters.

Essential Skills

• Experience with medical devices.
• Proficiency in shelf life testing.
• Understanding of product requirements and their clinical relevance.
• Experience with design verification and validation processes.
• Familiarity with Instron pull test machines.
• Ability to conduct DOEs testing.
• SolidWorks proficiency.
• 5-7 years of relevant experience.

Additional Skills & Qualifications

• Experience in injection molding is desirable.
• Experience through 1-2 product cycles.

Work Environment

The role is set in a dynamic startup environment with approximately 80-100 employees. Recently, the company received FDA 510(k) clearance and is entering the commercialization phase, with plans to expand R&D and manufacturing facilities by moving into a second building soon.