Research And Development Engineer

Key Responsibilities:

• Support design changes and conduct design change analysis for materials and components impacted by obsolescence.
• Ensure standards compliance (e.g., FDA, ISO) for material changes and documentation.
• Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Operations.
• Participate in and approve change notices; coordinate with vendors to collect and analyze technical data.
• Prepare DV (Design Verification) reports, protocols, and support submission documentation for regulatory changes.
• Manage documentation, including drawings, labeling updates, packaging changes, and part replacements.
• Potential hands-on work in the lab, but majority of the work is focused on documentation, compliance, and analysis.

Preferred Experience & Skills:

• 5 years of engineering experience in the medical device industry.
• Strong sustaining engineering background with hands-on experience in design and product lifecycle management.
• Experience with catheter devices – coronary catheters highly preferred.
• Understanding of systems engineering, especially with integrated catheter-capital systems.
• Proficiency with Windchill PLM system is a strong plus.
• Knowledge of FDA, ISO standards, and regulatory documentation requirements.
• Excellent communication skills and ability to work independently in a fast-paced environment.