Job Title: R&D Engineer

Job Description

This position supports the design and development of product changes within sustaining engineering and new product development for disposable medical devices. The role requires expertise in medical device design, focusing on Class II and Class III disposable products.

Responsibilities

• Design and develop product modifications and innovations within sustaining engineering projects.
• Lead new product development initiatives for disposable medical devices.
• Ensure compliance with FDA Design Controls and ISO Quality Management Systems.
• Apply risk management practices as per ANSI/AAMI/ISO standards in medical device development.
• Collaborate with cross-functional teams to optimize product design and functionality.

Essential Skills

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or a related field; Master's degree preferred.
• Minimum of 5 years of experience in Class II or Class III disposables medical product development.
• Proficiency in Design for Six Sigma (DFSS) principles.
• Strong knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
• Proficiency in CAD design and PDM enterprise software, such as Creo and Solidworks.

Additional Skills & Qualifications

• Certification in Design for Six Sigma (DFSS) is highly desirable.
• Experience with FDA Design Controls and ISO Quality Management Systems.
• Familiarity with ANSI/AAMI/ISO standards related to medical device risk management.

Work Environment

The position offers a hybrid work environment, allowing remote work on Mondays and Fridays, with in-office presence required on Tuesdays, Thursdays, and Fridays. Core working hours are from 9 AM to 3 PM.