Senior R&D Engineer

What You'll Do

• Leading small to medium-sized projects involving:
• Product enhancements and new features
• Supplier and material changes
• Labeling updates
• CAPA/NCR activities
• Cost reduction initiatives
• Product remediation efforts
• Identifying and solving complex engineering challenges using risk-based and customer-focused methodologies
• Developing and maintaining technical documentation, including:
• Design specifications
• Engineering drawings
• Validation protocols and reports
• Product labeling documentation
• Planning and executing:
• Verification & Validation (V&V)
• Product testing
• Test method validations
• Building prototypes and supporting fixture/tooling development for product evaluation and manufacturing support
• Ensuring compliance with FDA regulations, ISO standards, design controls, and quality system requirements

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related discipline
• 3+ years of experience developing or supporting Class II and/or Class III medical devices
• Experience with disposable medical product design and sustaining engineering activities

Technical Expertise

• Plastics processing technologies including injection molding, extrusion, ultrasonic welding, bonding processes, and sterilization methods
• CAD and Product Data Management (PDM) platforms such as Creo or SolidWorks
• FDA Design Controls and ISO 13485 Quality Management Systems
• Risk Management practices aligned with ISO 14971

Professional Attributes

• Self-starter with a strong sense of ownership and accountability
• Innovative mindset with a passion for continuous improvement
• Strong communication and cross-functional collaboration skills
• Highly organized with excellent attention to detail
• Able to manage multiple priorities in a fast-paced environment